Study on Entinostat and Aldesleukin for Treating Advanced Kidney Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01038778
This clinical trial is exploring a new treatment combining entinostat and aldesleukin to see if it can effectively treat kidney cancer that has spread to other parts of the body. The study aims to find the best dose and understand the side effects of this combination therapy.
Patient Parameters
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Program Overview
This study is testing a new treatment for kidney cancer that has spread beyond the kidneys. It combines two drugs: entinostat, which may stop cancer cells from growing, and aldesleukin, which may help the immune system attack cancer cells. The goal is to find out if this combination is safe and effective in shrinking tumors.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of entinostat when used with aldesleukin. In Phase II, they will evaluate how well this combination works in treating metastatic kidney cancer.
Participants will take entinostat by mouth every two weeks and receive aldesleukin through an IV every 8 hours for five days, followed by a break, and then another five days of treatment. This cycle may be repeated every 84 days if the cancer is responding well and side effects are manageable.
The study will also compare the effectiveness of this new treatment to historical data from patients who received only aldesleukin. Researchers will monitor participants for side effects, tumor response, and overall survival. They will also study how entinostat affects the body and cancer cells.
After completing the treatment, participants will have follow-up visits to monitor their health and any long-term effects of the therapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with kidney cancer that has spread or cannot be surgically removed, specifically clear cell carcinoma.
- May have had up to two previous treatments, including certain targeted therapies.
- Must have measurable or evaluable cancer.
- Good overall health with a performance status of 0, meaning fully active.
- Life expectancy of more than 6 months.
- Meet specific blood count and organ function criteria.
- No significant heart problems or recent heart attacks.
- No history of stroke or mini-strokes.
- Women of childbearing potential must use effective birth control during the study.
- Ability to understand and sign a consent form.
Exclusion Criteria
- More than two previous cancer treatments.
- Currently taking valproic acid or other investigational drugs.
- Untreated cancer spread to the brain.
- Medical conditions that could interfere with the study.
- Uncontrolled illnesses like severe heart disease or high blood pressure.
- Allergies to entinostat or similar medications.
- Pregnant or breastfeeding women.
- HIV-positive patients on antiretroviral therapy.
- Serious wounds or recent major surgery.
- Anticipation of needing major surgery during the study.
- Heart function below 45%.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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