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Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer

NCT01038778 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-04-13

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of entinostat when given together with aldesleukin and to see how well this works in treating patients with kidney cancer that has spread to other places in the body. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Aldesleukin may stimulate the white blood cells to kill kidney cancer cells. Giving entinostat together with aldesleukin may be a better treatment for metastatic kidney cancer.

Conditions

Interventions

BIOLOGICAL

Aldesleukin

Given IV

PROCEDURE

Computed Tomography

Undergo FDG-PET/CT

DRUG

Entinostat

Given PO

RADIATION

Fludeoxyglucose F-18

Undergo FDG-PET/CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET/CT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Saby George · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-29
Primary Completion
2019-05-22
Completion
2027-02-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038778 on ClinicalTrials.gov