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Spots Global Cancer Trial Database for Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

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Trial Identification

Brief Title: Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

Official Title: Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma

Study ID: NCT00030849

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.

Detailed Description: OBJECTIVES: * Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa. * Determine the safety and toxicity in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral bexarotene once daily for 8 weeks. Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity. Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: David J. Straus, MD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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