Study on High Dose IL-2 and Entinostat for Kidney Cancer

Sponsor: Roberto Pili

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Univeristy of Southern California90033Los AngelesCalifornia
Rush University Medical Center60612ChicagoIllinois
Indiana Univeristy Melvin and Bren Simon Cancer Center46202IndianapolisIndiana
Hematology Oncology Clinic, LLC70809Baton RougeLouisiana
Nebraska Methodist Hospital68114OmahaNebraska

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