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Hematology-Oncology Clinical Trials

The following searchable list includes all the Division of Hematology-Oncology - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials

NU 05H6: Acute Leukemias and Map Kinase

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and …

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells.

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
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NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those …

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas.

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.The purpose of this study is to learn about how CML leukemia cells …

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00039629
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NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop …

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00074258
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NUDB 13C03: Northwestern Brain Tumor Institute Research Database

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to …

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200435
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NU 15N01: Head and Neck Tissue Bank

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the …

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202177
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NU 15N02: Northwestern Head and Neck Cancer Registry

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine …

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck.

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202162
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NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell Clusters

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in …

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.

Shah, Ami NShah, Ami N
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203283
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NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.We are interested in learning about the …

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

VanderWeele, David JamesVanderWeele, David James
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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Melanoma and Skin Cancer Tissue Repository

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to …

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion.

Sosman, Jeffrey AlanSosman, Jeffrey Alan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer

This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal …
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT03392181 STU00205957
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(xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer

In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, …
In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03488693 STU00208897
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(xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.

This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the …

This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach?

The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer.

You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment.

Matei, Daniela ElenaMatei, Daniela Elena
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03660826 STU00208995
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(xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) …

The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer.

inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03598257 STU00209490
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(xIRB NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine or Vincristine Sulfate in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine sulfate in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may …

This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine sulfate in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine sulfate may work better in treating patients with acute lymphoblastic leukemia.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

- Participants must have a diagnosis of acute lymphoblastic leukemia, which has grown after their first treatment regimen or has recurred.

- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Dinner, Shira NaomiDinner, Shira Naomi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03504644 STU00210605
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BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma

This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. …
This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
Boumber, YanisBoumber, Yanis
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03942653 STU00210435
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(xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)

The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and …
The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

Some of the eligibility criteria include:

  • Participants must have a diagnosis of multiple myeloma
  • Participants must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Singhal, SeemaSinghal, Seema
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04133636 STU00210994
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(xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different …

Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

This study has two groups:

Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
Kircher, Sheetal MehtaKircher, Sheetal Mehta
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04094688 STU00211478
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(xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1Participants in this group willget less frequent monitoring. Participants …

The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

This study has 2 study groups:

Group 1

Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

Group 2

Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

Participants will be enrolled forup to five years.

Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.

Chawla, AkhilChawla, Akhil
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04239573 STU00213102
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(xirb) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to …

The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4. Some, but not all, of the risks and benefits of the drug are known.

You may be eligible to participate in this study if you have breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer; your cancer has spread to nearby tissues (locally advanced) or other areas of the body (metastatic); and you have also received previous anticancer therapy.

Participants may withdraw at any time.

Mulcahy, Mary FrancesMulcahy, Mary Frances
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04225117 STU00213246
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Nectin-4
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Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only …

Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212975
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(xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia

The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study …

The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods.

Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy.

This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2

Group 1

Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy.

Group 2

Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy.

Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study.

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NCT04214249 STU00213544
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(xIRB) NCI CIRB ETCTN 10334: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab) to the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will …

The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab)

to the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of pembrolizumab results in fewer detectable leukemia using new methods.

MK-3475 (pembrolizumab), is already approved by the FDA for use in several cancers.

However, MK-3475 (pembrolizumab) is not approved by the FDA or known to be safe for use in AML either alone or in combination with standard chemotherapy.

This study has 2 study groups. You will be told which group you are in.

Group 1

Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

depending on the results of your blood count. If you are unable to receive azacitidine over

the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

If you derive a clinical benefit within the first 6 cycles of therapy, you will continue

with the second part of therapy that consists of the same combination for up to 3 years

provided you do not stop responding at any time during the second part of therapy.

Group 2

Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

depending on the results of your blood count. If you are unable to receive azacitidine over

the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

You will receive MK-3475 (pembrolizumab) on Day 8 of the first cycle and every 3 weeks thereafter.

If you derive a clinical benefit within the first 6 cycles of therapy,

you will continue with the second part of therapy that consists of the same combination

for up to 3 years provided you do not stop responding.

Participants ages 60 years or older who have newly diagnosed AML will be enrolled in this study. 
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NCT04284787 STU00213545
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(xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may …

The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

analysis for up to 3 years from enrollment into the study.

Participants 18 years of age or older who have germ cell cancer will be enrolled.

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DRUG AT148002: A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and …
The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on your cancer when given together with AZA.

This Phase 1/2 study includes two parts. In the Phase 1 part of this study, increasing doses of ALX148 will be given together with AZA. In the Phase 2 part of the study, ALX148 will be given at a dose selected from the Phase 1 part in combination with AZA. Depending on the timing, you will participate in either the Phase 1 or Phase 2.

You will continue to receive treatment in the study as long as: you benefit from study treatment; you do not experience severe side effects; and you are willing to continue to undergo study-specific assessments. There is a 14-day screening period that will begin when you sign the consent form (up to 14 days before your first dose of ALX148), and a follow-up period for up to 3 years after your last dose of ALX148.

This study will consist of a screening visit(s) and multiple cycles of study treatment and evaluation that will involve multiple visits to the clinic, an end of study visit, and a follow-up visit(s). ALX148 is administered by an intravenous (through a vein) infusion lasting approximately 60-90 minutes in the clinic. AZA will be given once daily either by vein or by injection under the skin for 7 days, every 4 weeks.

The ALX148 study drug will be administered either every 2 or 4 weeks. AZA will be administered once daily for 7 days, every 4 weeks. A treatment cycle is 28 days both for ALX148 dosing every 2 or 4 weeks. It is possible that your treatment schedule may be changed. For example, your study doctor may start you on an every 4 week schedule and then change the schedule to every 2 weeks based on how well you tolerate the drug.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

•Age of at least 18 years

•Diagnosis of higher risk myelodysplastic syndrome (MDS) that is either no longer responsive to standard therapies of proven effectiveness and/or for which new safe and effective therapies need to be developed to improve outcomes.

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

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Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to …

The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

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ECOG-ACRIN 9181: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used …
This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab. We are doing this study because we want to find out if this approach is better or worse than the usual approach for you. The usual approach is defined as care most people get for ALL.
  • Participants must be 18 years or older
  • Participants must have a confirmed diagnosis of newly diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL).
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
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(xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

The purpose of this study is to compare the usual treatment alone to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment. We want to see if we can provide a more targeted treatment to this type of cancer by treating …

The purpose of this study is to compare the usual treatment alone

to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

whether adding apalutamide and directed radiation works better than the usual approach to help treat

prostate cancer that has returned after surgery.

This study will help the study doctors find out if this different approach is better than the usual

approach. To decide if it is better, the study doctors will be looking to see if the study approach

increases the time before cancer growth or if the cancer causes major additional symptoms.

This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

continue to follow your condition for up to 10 years and watch you for side effects and monitor the

progression of your cancer.

Group 1 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

Group 2 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

for 6 months.

Group 3 (Positive for Extra Pelvic-Metastases)

If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

You will get planned SOC RT + STAD + apalutamide for 6 months.

Group 4 (Positive for Extra Pelvic-Metastases)

If you are in this group, your cancer has spread to areas outside of your pelvis.

You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

which will take place about one year after starting treatment or if clinically necessary at an

earlier time point.

Male participants 18 years of age or older who have prostate cancer that has come back after surgery

will be enrolled into this study.

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NCT04423211 STU00214021
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NU 20H07: Social Correlates of Variation in Intestinal and Oral Microbiome Among Hematopoietic Stem Cell Transplant Patients: A Geographic Exploration in the City of Chicago

This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a …

This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

You may be eligible for this study if you have been diagnosed with a hematologic malignancy (also known as a blood cancer) and are being considered for an allogeneic hematopoietic stem cell transplantation (sometimes also referred to as a bone marrow transplant).

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DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors

The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is …
The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

  • To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
  • To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
  • To find the dose of Q702 that should be used in future studies.
  • To evaluate what the human body does and how the body reacts to Q702.

This research is being performed because improvements are needed in the treatment of patients with cancer.

We are asking you to take part in this research study because you have cancer that has continued to grow despite the treatments you have already received. Either the standard drugs and therapies used to treat your disease are no longer working or there are no known treatments which work because your tumor cells may be resistant to available treatments or you are not a candidate for or intolerant of available treatment. Your cancer had been confirmed by a pathologist (a person who studies the causes and effects of diseases).

This clinical trial tests a study drug, Q702. The study drug, Q702, targets certain molecules present in cancer cells that may help activate your body's immune system to fight the cancer. The study drug, Q702, is not approved for sale by the FDA.

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(xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer that has spread to the brain and come back in other areas of the brain after earlier treatment …

The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

(whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

This study will help the study doctors find out if this different approach is better, the same,

or worse than the usual approach.

Memantine is FDA approved for treating dementia and is commonly used off-label

(that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

radiation therapy for cancer that has spread to the brain.

This study has 2 study groups. You will be told which group you are in.

Group 1

If you are in this group, you will get the usual treatment, SRS. In addition to the usual

SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

Group 2

If you are in this group, you will get the usual treatment of SRS.

After you finish your treatment, your doctor and study team will watch you for side effects and

follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

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NCT04588246 STU00214371
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(xIRB) NCI CIRB Alliance A091902: A Multicenter Phase II Trial of Paclitaxel with and Without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects with Angiosarcoma

The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who …

The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who have eitherreceived paclitaxel or similar chemotherapy previously, or whose cancer hasgrown previously while getting paclitaxel chemotherapy on this study.

This study has 2 study groups.

Participants enrolledinto group 1 are those who have not received prior chemotherapy treatment withpaclitaxel or similar “taxane” chemotherapy. In this group, participants willbe assigned to one of two arms. In Arm 1, participants will receive combinationof paclitaxel and nivolumab. Participants assigned to Arm 2, will only receivepaclitaxel.

You will be put into astudy arm by chance. You will have a 50:50 chance of being in Arm 1 or Arm 2.If you are assigned to Arm 2 and your cancer gets worse you will have thechoice to receive cabozantinib and nivolumab if your doctor feels it wouldbenefit you.

Participantsenrolled into group 2 are those that have received prior chemotherapy treatmentwith paclitaxel or a similar “taxane” chemotherapy or participants who progresswhile in Group 1. In this group, participants will receive a combination ofcabozantinib and nivolumab.

After treatment is finished, participants will be followed every3 months for 3 years to be watched for side effects.

Participants ages 18 years or older who have a type of cancer called angiosarcoma.
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NCT04339738 STU00214492
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(xIRB) NCI CIRB SWOG 1931: Phase III Trial of Immunotherapy-Based Combination Therapy with or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of the kidney with tumor. All patients receive SST to shrink the tumor and stimulate the immunesystem. Participants who are benefiting from this treatment will be selected bychance to have …

The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of the kidney with tumor. All patients receive SST to shrink the tumor and stimulate the immunesystem. Participants who are benefiting from this treatment will be selected bychance to have surgery and then continue SST or continue SST without surgery. Thisstudy will help the study doctors find out which approach is better, the same,or worse.

Participantswho decide to take part in this study will get either only standard drugcombination therapy or will get the standard drug combination therapy andsurgery to remove part or all of their kidney. Participants will get treatment until their disease gets worse.

After study treatmentis completed, participants will be followed for up to 7 years to watch for sideeffects.

All of the drugs that are usedas part of treatment on this study are commercially available, FDA approved,and considered standard treatment for this type of kidney cancer.

Participants ages 18 years or older who havekidney cancer that has spread outside of the kidney will participate in this study.
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NCT04510597 STU00214655
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(xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)

The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be …

The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients compared to the usual approach.

This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.

Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.

Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.

After study treatment is finished, participants will be followed by the study doctor for up to 3 years.

Participants ages 18 years or older who have bladder cancer that has spread from the bladder to the lymph nodes will be enrolled into this study.

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NCT04216290 STU00214716
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(xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled. This study has two phases. Phase 1 and Phase 2. The purpose of Phase 1 …

Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

This study has two phases. Phase 1 and Phase 2.

The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

Patient must be ≥18 years.

Patient must have a diagnosis of BRAFV600E/K-mutated metastatic melanoma.

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NCT04557956 STU00214795
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(xIRB) NCI CIRB SWOG 1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or …

The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

After treatment is finished, participants will be followed for up to 10 years after enrollment.

Participants ages 18 years or older who have chronic lymphocytic leukemia or small lymphocytic lymphoma and who do not have symptoms and do not need to start treatment now will be enrolled into this study.

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NCT04269902 STU00214799
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(xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients …

The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

Stein, Regina MStein, Regina M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04457596 STU00214807
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NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion …

Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

Key eligibility criteria include:

  • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
  • Able to self-administer topical interventions or has available another person who can apply the topical agents
  • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
  • Age of at least 18 years old

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04469075 STU00213944
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NU 21B01: Volumetric Lumpectomy Specimen Image Visualization for Intraoperatively Directing Cavity Shaves, a Phase II Study (VIVID)

The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.If you are undergoing …

The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

· Age 18 or older

· Must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component

· Planning to undergo breast conservation surgery with planned localization and intraoperative imaging for the management of invasive breast cancer

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Kulkarni, SwatiKulkarni, Swati
  • Map it 201 E. Huron St.
    Chicago, IL
NCT05545150 STU00214652
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DRUG ALLO-605-201: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma

The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the …

The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the Food and Drug Administration (FDA) for use in the general public, although both treatments have been cleared for testing in clinical trials.

Pre-screening: Participants will have a blood test to determine eligibility for the main study.

Main study: Participants who qualify and agree to participate are expected to be in the study for approximately 36 months.

The screening period will last up to 28 days. Once screening is complete and participants are determined to be eligible, they will enter the treatment phase of the study.

While in the trial, participants will be asked to come to the clinic for approximately 27 study visits. At six of these visits participants will receive study treatment (i.e., lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647, or treatment with ALLO-605). The remaining visits will involve procedures to monitor safety, and to evaluate any effect on the participant’s multiple myeloma.

The study is made up of two parts. The first part is called dose escalation (Phase 1) and the second part is called dose expansion (Phase 2). In the dose escalation phase, the study will test different doses of ALLO-605, following lymphodepletion with a combination of medicines that includes different doses of ALLO-647, to determine safety and which is most effective. In the dose expansion phase of the study, one ALLO-605 dose level and a lymphodepleting regimen will be chosen for further evaluation, and additional patients treated with those doses.

Some of the eligibility criteria include:

•Age of at least 18 years

•Diagnosis of multiple myeloma

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Singhal, SeemaSinghal, Seema
NCT05000450 STU00215605
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NU 22H01: Serial Monitoring of Circulating Plasma Cells and Plasma Cell Components in Adults with Plasma Cell Disorders

This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand …

This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

You may be eligible for this research study if you have a plasma cell disorder.

Singhal, SeemaSinghal, Seema
STU00216869
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(xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center …

This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

· Participants must have a diagnosis of histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma

· Participants must be 18 or older

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Mulcahy, Mary FrancesMulcahy, Mary Frances
NCT05174169 STU00217884
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