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Histone Deacetylase Inhibitor

Romidepsin for Cancer and Chronic Lymphocytic Leukemia with Liver Dysfunction

Phase 1

Waitlist Available

Led By Roisin M Connolly

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 who have received prior romidepsin use are eligible

Patients must have histologically or cytologically confirmed lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor, and be refractory to standard therapy

Must not have

Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts

Uncontrolled intercurrent illness including ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 24, and 48 hours after initiation of the infusion on day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors.

Who is the study for?

This trial is for patients with lymphoma, chronic lymphocytic leukemia, or solid tumors who also have liver dysfunction. They must be relatively active (able to care for themselves), not have had certain cancers that didn't respond to previous phase 2 studies unless they are in moderate/severe liver dysfunction groups, and meet specific health criteria including blood counts and kidney function. Pregnant women and those with significant heart disease or on certain medications like warfarin cannot join.

What is being tested?

The trial is testing the effects of a drug called Romidepsin on various types of cancer in patients with liver problems. It aims to find the safest dose that can manage cancer growth by blocking proteins essential for cancer cell survival.

What are the potential side effects?

Romidepsin may cause side effects such as nausea, fatigue, infections due to low blood cell counts, changes in sense of taste, coughing, shortness of breath, and potential heart issues like irregular heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have previously been treated with romidepsin.

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My cancer does not respond to standard treatments anymore.

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I have a liver tumor, high alpha-fetoprotein levels, and hepatitis, indicating liver cancer.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

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I do not have prostate, renal cell, neuroendocrine, lung, colorectal cancers, soft tissue sarcomas, glioma, or thyroid cancer.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I do not have serious heart problems or recent heart attacks.

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I am not taking medications like rosiglitazone or pioglitazone.

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I am not taking Warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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 toxicity of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0

Maximum tolerated dose of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0

Pharmacokinetic (PK) profile of romidepsin in patients with varying degrees of hepatic dysfunction using liquid chromatography-electrospray ionization tandem mass spectrometric method

Secondary study objectives

Antitumor activity assessed using Response Evaluation Criteria in Solid Tumors and the International Workshop Lymphoma Response Criteria

Child-Pugh classification of hepatic dysfunction

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

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 (romidepsin)Experimental Treatment2 Interventions

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

2011

Completed Phase 2

~790

0 / 9Eligibility criteria met