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Study of CAbozantinib in Combination With AtezolizumaB for Muscle-Invasive BladdEr Cancer

Bladder

This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.
Bladder
II
Davis, Nancy
NCT04289779
VICCURO2044

Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study

Breast

This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4 / 6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4 / 6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1 / PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 / PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1 / PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.
Breast
II
Reid, Sonya
NCT04841148
VICCBRE2161

Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Liver

This phase II trial tests whether atezolizumab and bevacizumab after Y-90 TARE works to shrink tumors in patients with hepatocellular (liver) cancer that cannot be removed by surgery (unresectable). Transarterial radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to treat liver cancer. Tiny glass or resin beads filled with the radioactive isotope yttrium Y-90 are placed inside the blood vessels that feed the tumor. This blocks the supply of blood to the cancer cells and delivers a high dose of radiation to the tumor while sparing normal tissue. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Adding atezolizumab and bevacizumab after Y90 TARE may prevent liver cancer from returning for a longer period.
Liver
II
Goff, Laura
NCT04541173
VICCGI20110

Hypofractionated Radiotherapy Followed by Immediate Surgery for the Treatment of Soft Tissue Sarcomas

Sarcoma

This phase II trial studies the effect of hypofractionated radiotherapy followed by immediate surgery in treating patients with soft tissue sarcoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiotherapy followed by immediate surgery may allow patients with sarcomas to be treated in a much more rapid and convenient fashion.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062

Active Myeloid Target Compound Decitabine and Cedazuridine in Combination with Itacitinib for the Treatment of Myelodysplastic / Myeloproliferative Neoplasm (MDS / MPN) Overlap Syndromes, ABNL-MARRO Study

Multiple Cancer Types

This phase I / II trial tests the safety, side effects, and best dose of decitabine and cedazuridine (ASTX727) in combination with itacitinib and how well they work in treating patients with myelodysplastic / myeloproliferative neoplasm. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and cedazuridine in combination with itacitinib may work better in treating patients with myelodysplastic / myeloproliferative neoplasm.
Hematologic, Myelodysplastic Syndrome
I/II
Savona, Michael
NCT04061421
VICCHEMP1977

Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination with Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients

Leukemia

This phase Ib / II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is an enzyme inhibitor. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Venetoclax and decitabine are commonly given together for older patients with AML ASTX727 (a pill form of decitabine + cedazuridine) has been found to be equal to decitabine (given intravenously), and this part of the study is to confirm that venetoclax and ASTX727 is as safe as venetoclax and decitabine given intravenously. This study allows for lowering doses of study drugs to assure the dose chosen for the randomized study (second portion of this trial) is safe and tolerable for people. Giving ASTX727 in combination with venetoclax may help in the treatment of patients with higher-risk acute myeloid leukemia.
Leukemia
I/II
Savona, Michael
NCT04817241
VICCNCIHEM10417

Metabolism Informed Smoking Treatment for Smoking Cessation in Medicaid and Medicare Patients

Miscellaneous

This phase III trial compares the effect of a metabolism informed smoking treatment (MIST) to standard therapy to help Medicaid and Medicare patients quit smoking. Quitting smoking can help prevent smoking-related diseases like cancer and heart disease and can help patients live longer. MIST includes a free screening blood test to show how fast the body breaks down nicotine in order to help people quit smoking. The screening test is the first step to a study that may help doctors choose the best medication to quit smoking.
Miscellaneous
III
Tindle, Hilary
NCT04590404
VICCTHO2046

Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant

Multiple Cancer Types

This phase I / II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
Hematologic, Pediatric Leukemia, Pediatric Lymphoma
I/II
Kitko, Carrie
NCT03842696
VICCPED2133

Ifetroban in Treating Patients with Malignant Solid Tumors at High Risk of Metastatic Recurrence

Multiple Cancer Types

This phase II trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment (recurrent) and spreading throughout the body (metastatic). Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body.
Breast, Esophageal, Gastric/Gastroesophageal, Lung, Non Small Cell, Pancreatic, Small Cell
II
Reid, Sonya
NCT03694249
VICCMD1854

Ketogenic Diet with Letrozole in Treating Patients with Estrogen Receptor Positive Breast Cancer

Breast

This early phase I trial studies how well ketogenic diet with letrozole works in treating patients with estrogen receptor positive breast cancer. Estrogen receptor positive breast cancer has special proteins on it, called estrogen receptors, that allow it to grow when exposed to estrogen. A ketogenic diet (low calorie, low carbohydrate) may help normalize abnormally high insulin levels that in turn may slow the growth of cancer cells. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this study is to learn if the combination of a 2 week ketogenic diet in combination with letrozole can help slow the growth of tumors.
Breast
Early I
Rexer, Brent
NCT03962647
VICCBRE18108