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HCRN GU17-289

Status:

Open | Phase II

Official Title:

A Phase II Randomized, Open label Study of High Dose Interleukin 2 vs High Dose Interleukin 2 plus Entinostat in Untreated Advanced Renal Cell Carcinoma

Study Purpose:

To determine if adding entinostat, a drug that helps treat cancer, to the standard treatment for advanced kidney cancer will control the cancer longer than the standard treatment alone. 

Interventions:

  • Study agents: Entinostat, High Dose Interleukin 2
  • ARM 1: High dose interleukin 2 IV every 8 hours on day 1-5 and day 15-19 and Entinostat PO once every 2 weeks for 84 days.  Patients may continue Entinostat until their cancer gets worse, or they need to stop the drug for another reason such as unacceptable toxicity.
  • ARM 2: High dose interleukin 2 IV every 8 hours on day 1-5 and day 15-19.
    Patients are evaluated after each 84 day cycle and may receive up to 3 courses of high dose interleukin 2 treatment.   

After treatment is complete patients will be followed for at least 2 ½ years.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Renal clear cell carcinoma

Eligibility:

Patients must have metastatic disease or locally advanced disease that cannot be removed with surgery.

Patients must have acceptable heart and lung function to enroll in this trial.

Patients cannot be taking or plan to take any prescription AND/OR over the counter medications that reduces clotting such as aspirin and ibuprofen.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

HCRN GU17-289

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!