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ACTIVE_NOT_RECRUITINGPHASE2

High Dose IL 2 and Entinostat in RCC

A Phase II Randomized, Open Label Study of High Dose Interleukin 2 vs High Dose Interleukin 2 Plus Entinostat in Advanced Renal Cell Carcinoma

NCT03501381•Roberto Pili

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose interleukin 2). Subjects will receive up to 3 courses of high dose interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19 (maximum 28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14, continuously. Tumor response assessment will be performed between HD IL-2 courses.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at the time of consent.
•ECOG Performance Status of 0 within 14 days prior to registration.
•Life expectancy of greater than 6 months.
•Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable. The histology must be clear cell carcinoma or predominant clear cell carcinoma.
•Patients must have measurable or evaluable disease by RECIST 1.1.
•Up to two prior therapies for RCC are allowed. One prior therapy must contain an immune checkpoint inhibitor.Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
•White blood cell (WBC) ≥ 3,000 K/mm3
•Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
•Leukocytes ≥ 3,000/mm3
•Platelets ≥ 100,000/mm3
+20 more criteria

Exclusion Criteria

•Prior treatment with HD IL-2
•Concurrent use of valproic acid use is not allowed.
•Receiving medications that can effect clotting ability: warfarin, aspirin (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents.
•Patients may not be receiving other investigational agents.
•Active infection requiring systemic therapy
•Pregnant or breastfeeding
•Any prior history of other cancer within the prior 5 years with the exception of adequately treated basal cell carcinoma, cervical intraepithelial neoplasia \[CIN\]/cervical carcinoma in situ, melanoma in situ or ductal carcinoma in situ \[DCIS\], localized Gleason 6 prostate cancer, papillary thyroid cancer or other non-melanoma skin cancers.
•Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association Class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (\< the last 6 months), cardiac arrhythmia, history of CVA within 6 months, hypertension (defined as blood pressure of \>160 mmHg systolic and/or \>90 mmHg diastolic on medication), QTc interval \> 470 msec, history of peripheral vascular disease, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study

Locations (5)

Univeristy of Southern California

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana Univeristy Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Hematology Oncology Clinic, LLC

Baton Rouge, Louisiana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Key Dates

Start Date

May 24, 2018

Primary Completion Date

January 20, 2023

Completion Date

April 1, 2024

Last Updated

September 1, 2023

Enrollment

ESTIMATED participants

Conditions

Renal Cell Carcinoma

Interventions

Entinostat

DRUG

Interleukin-2

DRUG

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RECRUITINGNA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

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Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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High Dose IL 2 and Entinostat in RCC

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma