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Cytokine

IL-2 + Entinostat for Kidney Cancer

Phase 2
Waitlist Available
Led By Roberto Pili, MD
Research Sponsored by Roberto Pili
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must have a negative serum pregnancy test during screening and within 3 days prior to receiving first dose of study medication
Age ≥ 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new combination treatment for kidney cancer.

Who is the study for?
Adults with clear cell renal cell carcinoma, who can tolerate high doses of interleukin-2 and have not had certain recent cancers or major surgeries. They must be in good physical condition with well-functioning organs, not pregnant, willing to use contraception, and without serious infections or heart issues.Check my eligibility
What is being tested?
The trial is testing the effectiveness of high dose interleukin-2 alone versus combined with entinostat in treating kidney cancer. Patients are randomly assigned to one of two groups and receive up to three courses of treatment, with tumor assessments between courses.See study design
What are the potential side effects?
High dose interleukin-2 can cause flu-like symptoms, low blood pressure, fatigue, nausea, diarrhea and may affect heart rhythm. Entinostat could potentially cause fatigue, inflammation in the lungs or liver problems. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and have a recent negative pregnancy test.
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I am 18 years old or older.
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I have been fully active without restrictions in the past 2 weeks.
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I've had radiation for cancer spread, but there's a part of my cancer that hasn't been treated with radiation.
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I agree to use birth control or abstain from sex during and 90 days after treatment.
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My heart is healthy with no recent major issues.
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I have never had a stroke, mini-stroke, or brain cancer.
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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 is good, meeting the required FEV1 levels.
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I have had up to two treatments for kidney cancer, one of which included an immune therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Assess Adverse Events
Duration of response
Objective Response Rate
+1 more

Side effects data

From 2014 Phase 2 trial • 13 Patients • NCT01105650
100%
Neutropenic fever
100%
Chills
100%
Dyspnea
100%
Edema
67%
Hypotension
67%
Death NOS
67%
Fever
67%
Hypertension
67%
Hypoxia
33%
Double vision
33%
Foot pain
33%
Acute kidney injury
33%
Confusion/Disoriented
33%
Blurred vision
33%
Dizziness
33%
Atrial fibrillation
33%
Vestibular disorder
33%
Hearing loss
33%
Ascites
33%
Hearing impairmed
33%
Hallucinations
33%
Headache
33%
Rash/Desquamation
33%
Depressed level of consciousness
33%
Strange dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2
Arm 1: CsA
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose Interleukin 2 plus EntinostatExperimental Treatment2 Interventions
HD IL-2 600,000 IU/kg Every 8 hours on Days 1-5 and Days 15-19 plus Entinostat 5 mg orally every 2 weeks starting Day -14
Group II: High Dose Interleukin 2Active Control1 Intervention
HD IL-2 600,000 IU/kg Every 8 hours on Days 1-5 and Days 15-19
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entinostat
2017
Completed Phase 2
~1170
Interleukin-2
1994
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Clinigen, Inc.Industry Sponsor
9 Previous Clinical Trials
311 Total Patients Enrolled
Roberto PiliLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Indiana University Melvin and Bren Simon Cancer CenterOTHER
5 Previous Clinical Trials
642 Total Patients Enrolled

Media Library

Interleukin-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT03501381 — Phase 2
Kidney Cancer Research Study Groups: High Dose Interleukin 2 plus Entinostat, High Dose Interleukin 2
Kidney Cancer Clinical Trial 2023: Interleukin-2 Highlights & Side Effects. Trial Name: NCT03501381 — Phase 2
Interleukin-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03501381 — Phase 2

Frequently Asked Questions

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

In how many hospitals is this research being conducted?

"There are 5 enrolling patients for this clinical trial at the Indiana Univeristy Melvin and Bren Simon Cancer Center in Indianapolis, Nebraska Methodist Hospital in Omaha, and Univeristy of Southern California in Los Angeles."

Answered by AI

Do we have a precedent for the use of Interleukin-2 in medical research?

"As of this moment, 78 research trials involving Interleukin-2 are currently ongoing with 7 in Phase 3. A majority of these clinical studies originate from Boston, Massachusetts; however, 1169 locations worldwide are trialing Interleukin-2."

Answered by AI

Are participants being recruited for this trial at the current moment?

"According to the latest update on clinicaltrials.gov, this particular study is not currently looking for patients. This trial was initially posted on May 24th, 2018 and was updated as recently as February 14th, 2022. Although this research isn't recruiting at the moment, there are 2745 other studies that are actively seeking participants."

Answered by AI

Has the Federal Drug Administration given their blessing to Interleukin-2?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that Interleukin-2 is safe."

Answered by AI

How many participants are being asked to join this research project?

"Unfortunately, this cancer research trial is no longer looking for patients. It was originally posted on May 24th, 2018 but the most recent edit was on February 14th, 2022. However, there are 2667 other trials for carcinoma and 78 trials involving Interleukin-2 that are still admitting patients."

Answered by AI
~7 spots leftby Mar 2025