High Dose IL 2 and Entinostat in RCC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

January 20, 2023

Study Completion Date

April 30, 2024

Conditions
Renal Cell Carcinoma
Interventions
DRUG

Entinostat

Entinostat should be taken 1-2 hours prior to the HD IL-2 infusion. Dose reductions for entinostat should be followed. Entinostat will continue after high dose IL-2 every 2 weeks

DRUG

Interleukin-2

In the event of clinical benefit after a course of HD IL-2 (stable disease or tumor shrinkage) patients will receive a second treatment course of HD IL-2 therapy. Patients with evidence of tumor shrinkage after the 2nd HD IL-2 treatment course may receive a 3rd treatment course of HD IL-2.

Trial Locations (5)

46202

Indiana Univeristy Melvin and Bren Simon Cancer Center, Indianapolis

60612

Rush University Medical Center, Chicago

68114

Nebraska Methodist Hospital, Omaha

70809

Hematology Oncology Clinic, LLC, Baton Rouge

90033

Univeristy of Southern California, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Indiana University Melvin and Bren Simon Cancer Center

OTHER

collaborator

Syndax Pharmaceuticals

INDUSTRY

collaborator

Clinigen, Inc.

INDUSTRY

lead

Roberto Pili

OTHER