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IL-2 + Entinostat for Kidney Cancer
Study Summary
This trial is testing a new combination treatment for kidney cancer.
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.Side effects data
From 2014 Phase 2 trial • 13 Patients • NCT01105650Trial Design
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Who is running the clinical trial?
Media Library
- I am a woman who can have children and have a recent negative pregnancy test.I am taking medications that can affect blood clotting.You must have a way for doctors to measure or evaluate your disease according to a specific set of guidelines.Your heart's pumping function is less than 45%.Your white blood cell count is equal to or greater than 3,000 per cubic millimeter.You have enough infection-fighting white blood cells in your body.You have at least 100,000 platelets per cubic millimeter of blood.Your hemoglobin level is higher than 12 grams per deciliter.Your AST level in the blood is not more than 2.5 times the normal upper limit.Your liver enzyme levels (ALT) should be no more than 2.5 times the normal limit.Your lactate dehydrogenase levels are normal.I agree to use birth control or abstain from sex during and 90 days after treatment.My heart is healthy with no recent major issues.I haven't had any other cancers in the last 5 years, except for certain treated types.I do not have any severe illnesses that are not under control.I am HIV-positive, on effective treatment, and my HIV is under control.I have a serious or non-healing wound, ulcer, or bone fracture.I expect to need major surgery during the study.I am 18 years old or older.I have been fully active without restrictions in the past 2 weeks.I've had radiation for cancer spread, but there's a part of my cancer that hasn't been treated with radiation.Your kidneys work well enough to filter out waste from your blood.Your blood clotting tests should not be more than 1.5 times the upper limit of normal.I have never had a stroke, mini-stroke, or brain cancer.Your kidney function, as measured by a blood test, is within a certain range.I have active hepatitis B or C.My kidney cancer cannot be removed by surgery and is mostly clear cell type.I have previously been treated with high-dose interleukin-2.Your urine protein level should be low, and if it's higher, a special urine test should show that it's not too high.Your corrected calcium level is less than or equal to 10 mg/dL.You have a high level of white blood cells.I haven't had major surgery or a serious injury in the last 28 days.You are expected to live for at least 6 more months.I am currently taking valproic acid.I am currently on medication for an infection.Your total bilirubin levels must be within a certain range in your blood test.My lung function is good, meeting the required FEV1 levels.I have had up to two treatments for kidney cancer, one of which included an immune therapy.
- Group 1: High Dose Interleukin 2 plus Entinostat
- Group 2: High Dose Interleukin 2
- 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
In how many hospitals is this research being conducted?
"There are 5 enrolling patients for this clinical trial at the Indiana Univeristy Melvin and Bren Simon Cancer Center in Indianapolis, Nebraska Methodist Hospital in Omaha, and Univeristy of Southern California in Los Angeles."
Do we have a precedent for the use of Interleukin-2 in medical research?
"As of this moment, 78 research trials involving Interleukin-2 are currently ongoing with 7 in Phase 3. A majority of these clinical studies originate from Boston, Massachusetts; however, 1169 locations worldwide are trialing Interleukin-2."
Are participants being recruited for this trial at the current moment?
"According to the latest update on clinicaltrials.gov, this particular study is not currently looking for patients. This trial was initially posted on May 24th, 2018 and was updated as recently as February 14th, 2022. Although this research isn't recruiting at the moment, there are 2745 other studies that are actively seeking participants."
Has the Federal Drug Administration given their blessing to Interleukin-2?
"While Phase 2 trials don't have data supporting efficacy, there is some evidence that Interleukin-2 is safe."
How many participants are being asked to join this research project?
"Unfortunately, this cancer research trial is no longer looking for patients. It was originally posted on May 24th, 2018 but the most recent edit was on February 14th, 2022. However, there are 2667 other trials for carcinoma and 78 trials involving Interleukin-2 that are still admitting patients."
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