Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00030849
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States