Romidepsin for Cancer and Chronic Lymphocytic Leukemia with Liver Dysfunction

Palo Alto (17 mi)

Overseen byRoisin Connolly, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.

Eligibility Criteria

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.

Inclusion Criteria

I have previously been treated with romidepsin.

My cancer does not respond to standard treatments anymore.

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

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

Exclusion Criteria

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

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

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

I am not taking medications like rosiglitazone or pioglitazone.

I am not taking Warfarin.

Treatment Details

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.

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.

Romidepsin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Istodax for: