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Entinostat + Aldesleukin for Kidney Cancer
Study Summary
This trial is testing a combination of drugs to treat metastatic kidney cancer. Entinostat may stop tumor cell growth, and aldesleukin may stimulate white blood cells to kill cancer cells. The goal is to see if this combination is more effective than current treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I've had up to two treatments for my cancer and may have had radiation, but still have measurable cancer.I am not allergic to entinostat or similar medications.I am not HIV-positive or taking antiretroviral therapy.Your heart's pumping ability is less than 45%.You are expected to live for at least 6 more months.Your lactate dehydrogenase (LDH) levels are normal.I am fully active and can carry on all pre-disease activities without restriction.I agree to use birth control during the study and will inform my doctor if I or my partner becomes pregnant.I have brain metastases that haven't been treated, or I've had successful surgery/radiation for a few brain metastases.I do not have any severe illnesses that are not under control.I have no recent heart issues and, if over 40 or with past heart attacks, I've passed a recent heart stress test.Patients must have a disease that can be measured or evaluated.Your blood's ability to clot is within a normal range.I have a serious or non-healing wound, ulcer, or bone fracture.I have never had a stroke or a mini-stroke.I haven't had major surgery or a serious injury in the last 28 days.You need to have a certain number of a type of white blood cells called neutrophils in your blood.Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal.I expect to undergo major surgery during the study.Your hemoglobin level is at least 12 grams per deciliter.I am not pregnant and will stop breastfeeding if treated with entinostat.You have a low level of white blood cells.I am not taking valproic acid.You have a medical condition that would make it hard for the doctors to check if the study treatment is safe.Your corrected calcium level is less than or equal to 10 mg/dL.My kidney function, measured by creatinine levels, is within the normal range.Your bilirubin level is within the normal range set by the laboratory.You have enough platelets in your blood (at least 100,000 per cubic millimeter).My kidney cancer cannot be removed by surgery and is mostly clear cell type.I have had more than two previous treatments.My lung function test shows I can breathe out at least 2 liters of air in one second.Your urine protein level is less than 1+. If it's 1+ or more, a 24-hour urine protein test should show that it's less than 1000 mg.
- Group 1: Treatment (entinostat, aldesleukin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the goal of this clinical research?
"The primary outcome of this study is to measure the dose-limiting toxicities of entinostat when combined with aldesleukin over a period of 12 months. Secondary objectives include changes in tumor metabolism, as measured by FDG positron emission tomography (PET)/computed tomography (CT) scan, and changes in the level of specific T lymphocytes. The study will also measure time-to-tumor progression."
Are there other drugs that have been studied in combination with Entinostat?
"There are currently 78 clinical trials underway to study the effects of entinostat. This includes 7 Phase 3 studies. Most of these studies are based in Boston, but there are 1169 research sites in total across the globe."
How many people total are enrolled in this research project?
"This clinical trial is no longer recruiting patients. The study was originally posted on October 29th, 2009 and was most recently updated on June 28th, 2022. If you are searching for other studies, there are currently 2719 studies actively recruiting participants with carcinoma, renal cell and 78 trials for Entinostat actively looking for patients."
How many locations are conducting this research project?
"4 sites are currently enrolling patients for this trial, with locations in Buffalo, Columbus, Los Angeles and 4 other cities. To cut down on travel costs and time requirements, please select the clinical trial site nearest to you."
Are we still enrolling patients for this clinical trial?
"As of right now, this clinical trial is not admitting any new patients. The study was originally posted on October 29th, 2009 and was last edited on June 8th, 2020. For individuals searching for other trials, there are 2719 active clinical trials for carcinoma and 78 Entinostat trials that are currently accepting patients."
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