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NCT01038778 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
47
Enrollment target
4
Study locations

NCT01038778: Active Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

NCT01038778 is a Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01038778, a Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
47 participants
Enrollment target
4
Study locations

Study 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.

Primary Outcome

Number of dose-limiting toxicities of entinostat when combined with aldesleukin within the Phase I MEASUREMENT OF EFFECT Patients underwent CT scans at week 11 (+/- 7 days) of each cycle during aldesleukin administration and then every 8-12 weeks (+/- 2 weeks). Response Evaluation Criteria in Solid Tumors (RECIST V.1.0)

Conditions Studied

Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v7 Metastatic Kidney Carcinoma Stage III Renal Cell Cancer AJCC v7

Interventions

  • PROCEDURE Computed Tomography
  • OTHER Laboratory Biomarker Analysis
  • DRUG Entinostat
  • RADIATION Fludeoxyglucose F-18
  • BIOLOGICAL Aldesleukin

Study Locations (4)

California

  • USC / Norris Comprehensive Cancer Center - Los Angeles

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

New York

  • Roswell Park Cancer Institute - Buffalo

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2009-10-29
Est. Completion 2027-02-12
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT01038778 still lists

NCT01038778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (77% lower).

The record links to 4 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.

NCT01038778 reports a single indexed study location in California, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT01038778 about?

NCT01038778 is a clinical study titled "Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer". 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 en...

What is the current status of trial NCT01038778?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2009-10-29. Estimated completion is 2027-02-12.

What conditions does trial NCT01038778 study?

This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7.

What interventions are being tested in trial NCT01038778?

The interventions under investigation include: Computed Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Entinostat (DRUG), Fludeoxyglucose F-18 (RADIATION), Aldesleukin (BIOLOGICAL).

Who is sponsoring clinical trial NCT01038778?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01038778 being conducted?

This trial has 4 study locations across California, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Clear Cell Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01038778's enrollment target sits among peer trials

47 34th of 45 higher than 12 of 45 other Clear Cell Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01038778, the US trial registry maintained by the National Library of Medicine. NCT01038778 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.