Romidepsin for Cancer and Chronic Lymphocytic Leukemia with Liver Dysfunction

Recruiting at 11 trial locations

Overseen by Roisin 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.

Research Team

Roisin Connolly, MD

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

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.

You need to have a certain level of red blood cells, white blood cells, platelets, and a substance called creatinine in your blood.

I have relapsed or refractory PTCL or CTCL without time restrictions on my last treatment.

Exclusion Criteria

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

I haven't had major surgery or antibody therapies recently.

Patients may not be receiving any other investigational agents

Treatment Details

Interventions

• Romidepsin (Histone Deacetylase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (romidepsin) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University