CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 47 enrolled
Drug / intervention
Aldesleukin +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01038778
NCT01038778Phase 2Active
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Phase I/II Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma

National Cancer Institute (NCI)·interventional·Posted Dec 24, 2009·Updated Apr 13, 2026

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Computed Tomography, and 5 other interventions for Clear Cell Renal Cell Carcinoma and 3 related conditions. Active but no longer recruiting, targeting 47 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2009
Enrollment StartOct 29, 2009
Primary CompletionMay 22, 2019
Study CompletionFeb 12, 2027
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 16.5 years ago

Interventions

Aldesleukinbiological

Given IV

Computed Tomographyprocedure

Undergo FDG-PET/CT

Entinostatdrug

Given PO

Fludeoxyglucose F-18radiation

Undergo FDG-PET/CT

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Positron Emission Tomographyprocedure

Undergo FDG-PET/CT