Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
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.
Interventional
Primary Purpose: Treatment
David J. Straus, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000069202
NCT00030849
October 2001
December 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Abramson Cancer Center of the University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104-4283 |