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Immunotherapy

Entinostat + Aldesleukin for Kidney Cancer

Phase 1 & 2
Waitlist Available
Led By Saby George
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients may have received up to two prior therapies including vascular endothelial growth factor (VEGF), mammalian target of rapamycin (mTOR) and programmed cell death (PD)-1/PD ligand 1 (L1) inhibitors; 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
Eastern Cooperative Oncology Group (ECOG) performance status 0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to approximately 4 weeks post-treatment, up to 1 year
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat metastatic kidney cancer. Entinostat may stop tumor cell growth, and aldesleukin may stimulate white blood cells to kill cancer cells. The goal is to see if this combination is more effective than current treatments.

Who is the study for?
This trial is for adults with metastatic kidney cancer who have good physical function and a life expectancy over 6 months. They can have had up to two prior treatments, but not more, and must be able to perform daily activities without significant difficulty (ECOG status 0). Participants need normal organ function tests, no recent heart issues or strokes, and non-pregnant women/men must agree to use contraception. People with certain medical conditions or those on conflicting medications cannot join.Check my eligibility
What is being tested?
The trial is testing the combination of entinostat (which blocks enzymes needed for tumor growth) with aldesleukin (which may activate white blood cells against cancer) in patients with advanced kidney cancer. It aims to find the best dose of entinostat that works well with aldesleukin by observing side effects and effectiveness.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as flu-like symptoms from aldesleukin, fatigue, possible liver enzyme changes due to entinostat, and other common chemotherapy-related side effects like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had up to two treatments for my cancer and may have had radiation, but still have measurable cancer.
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I am fully active and can carry on all pre-disease activities without restriction.
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I agree to use birth control during the study and will inform my doctor if I or my partner becomes pregnant.
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I have no recent heart issues and, if over 40 or with past heart attacks, I've passed a recent heart stress test.
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I have never had a stroke or a mini-stroke.
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My kidney function, measured by creatinine levels, is within the normal range.
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My kidney cancer cannot be removed by surgery and is mostly clear cell type.
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My lung function test shows I can breathe out at least 2 liters of air in one second.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to approximately 4 weeks post-treatment, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately 4 weeks post-treatment, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I
Overall Response Rate (Complete Plus Partial) (Phase II)
Secondary outcome measures
Changes in Tumor Metabolisms by FDG Positron Emission Tomography (PET)/Computed Tomography (CT) Scan
Changes in the Level of Specific T Lymphocytes
Incidence of Toxicities
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (entinostat, aldesleukin)Experimental Treatment7 Interventions
Patients receive entinostat PO every 2 weeks beginning on day -14 and high-dose aldesleukin IV every 8 hours on days 1-5 and 15-19. Cycles repeat every 84 days* in the absence of disease progression or unacceptable toxicity. NOTE: *Patients with evidence of tumor shrinkage may receive up to 3 cycles of high-dose aldesleukin therapy. Patients with stable disease by RECIST version 1.0 criteria, but without evidence of tumor shrinkage after two cycles will receive only entinostat until disease progression is documented.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Computed Tomography
2017
Completed Phase 2
~2790
Entinostat
2017
Completed Phase 2
~1170
Positron Emission Tomography
2008
Completed Phase 2
~2260
Fludeoxyglucose F-18
2018
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,599 Total Patients Enrolled
Saby GeorgePrincipal InvestigatorRoswell Park Cancer Institute
5 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Aldesleukin (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01038778 — Phase 1 & 2
Renal Cell Carcinoma Research Study Groups: Treatment (entinostat, aldesleukin)
Renal Cell Carcinoma Clinical Trial 2023: Aldesleukin Highlights & Side Effects. Trial Name: NCT01038778 — Phase 1 & 2
Aldesleukin (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01038778 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the goal of this clinical research?

"The primary outcome of this study is to measure the dose-limiting toxicities of entinostat when combined with aldesleukin over a period of 12 months. Secondary objectives include changes in tumor metabolism, as measured by FDG positron emission tomography (PET)/computed tomography (CT) scan, and changes in the level of specific T lymphocytes. The study will also measure time-to-tumor progression."

Answered by AI

Are there other drugs that have been studied in combination with Entinostat?

"There are currently 78 clinical trials underway to study the effects of entinostat. This includes 7 Phase 3 studies. Most of these studies are based in Boston, but there are 1169 research sites in total across the globe."

Answered by AI

How many people total are enrolled in this research project?

"This clinical trial is no longer recruiting patients. The study was originally posted on October 29th, 2009 and was most recently updated on June 28th, 2022. If you are searching for other studies, there are currently 2719 studies actively recruiting participants with carcinoma, renal cell and 78 trials for Entinostat actively looking for patients."

Answered by AI

How many locations are conducting this research project?

"4 sites are currently enrolling patients for this trial, with locations in Buffalo, Columbus, Los Angeles and 4 other cities. To cut down on travel costs and time requirements, please select the clinical trial site nearest to you."

Answered by AI

Are we still enrolling patients for this clinical trial?

"As of right now, this clinical trial is not admitting any new patients. The study was originally posted on October 29th, 2009 and was last edited on June 8th, 2020. For individuals searching for other trials, there are 2719 active clinical trials for carcinoma and 78 Entinostat trials that are currently accepting patients."

Answered by AI
~3 spots leftby Mar 2025