Study on High Dose IL-2 and Entinostat for Kidney Cancer
Sponsor: Roberto Pili
ClinicalTrials ID:NCT03501381
This clinical trial is testing whether adding the drug entinostat to high dose interleukin-2 (IL-2) can improve treatment outcomes for patients with advanced kidney cancer. Participants will receive either high dose IL-2 alone or in combination with entinostat.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if combining high dose interleukin-2 (IL-2) with the drug entinostat can better treat patients with advanced kidney cancer, specifically clear cell renal cell carcinoma. Participants will be randomly assigned to receive either high dose IL-2 alone or with entinostat. The treatment involves receiving IL-2 through an IV every 8 hours for 5 days, with a break, and possibly taking entinostat orally every two weeks. The study will assess how well the tumors respond to these treatments.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a good performance status, meaning able to carry out daily activities without significant limitations.
- Expected to live more than 6 months.
- Have advanced kidney cancer that cannot be surgically removed, specifically clear cell type.
- Have measurable cancer that can be tracked using standard criteria.
- Allowed to have had up to two previous treatments for kidney cancer, including one with an immune checkpoint inhibitor.
- Must meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after.
- Men must agree to use contraception during the study and for 90 days after.
- Must have good lung and heart function, with no recent heart attacks or severe heart conditions.
- No history of stroke or brain metastases unless treated and stable for 6 months.
Exclusion Criteria
- Have previously received high dose IL-2 treatment.
- Currently taking valproic acid or medications affecting blood clotting, except for low-dose aspirin.
- Participating in another clinical trial or taking investigational drugs.
- Have an active infection requiring treatment.
- Pregnant or breastfeeding.
- Have had another cancer within the last 5 years, except for certain skin or localized cancers.
- Have uncontrolled medical conditions, such as severe heart disease, high blood pressure, or diabetes.
- Have HIV, unless well-controlled with medication.
- Have active hepatitis B or C infections.
- Have serious wounds or recent major surgery.
- Have a heart pumping ability below 45%.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Univeristy of Southern California | 90033 | Los Angeles | California |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| Indiana Univeristy Melvin and Bren Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Hematology Oncology Clinic, LLC | 70809 | Baton Rouge | Louisiana |
| Nebraska Methodist Hospital | 68114 | Omaha | Nebraska |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
