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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

Eastern Cooperative Oncology Group (ECOG) performance status 0

No history of cerebrovascular accident or transient ischemic attacks

Must not have

Patients with a history of allergy to entinostat or other medications that have a benzamide structure (i.e. tiapride, remoxipride, and clebopride)

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 cerebrovascular accident (CVA) within 6 months, hypertension (defined as blood pressure of > 160 mmHg systolic and/or > 90 mmHg diastolic on medication) history of peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to approximately 4 weeks post-treatment, up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 am fully active and can carry on all pre-disease activities without restriction.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to entinostat or similar medications.

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I do not have any severe illnesses that are not under control.

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I have a serious or non-healing wound, ulcer, or bone fracture.

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I haven't had major surgery or a serious injury in the last 28 days.

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I expect to undergo major surgery during the study.

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I am not pregnant and will stop breastfeeding if treated with entinostat.

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I am not taking valproic acid.

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I have had more than two previous treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to approximately 4 weeks post-treatment, up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I

Overall Response Rate (Complete Plus Partial) (Phase II)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1610

Computed Tomography

2017

Completed Phase 2

~2740