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Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed by bexarotene may be an effective treatment for cutaneous T-cell lymphoma. PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by bexarotene works in treating patients with cutaneous T-cell lymphoma.
OBJECTIVES: Primary * Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell lymphoma treated with doxorubicin HCl liposome followed by bexarotene. Secondary * Determine the complete and partial response rate in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks. Patients who achieve a complete or partial response may continue to receive bexarotene in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Start Date
November 1, 2005
Primary Completion Date
October 1, 2017
Completion Date
October 1, 2017
Last Updated
August 16, 2018
37
ACTUAL participants
Targretin® (bexarotene)
DRUG
pegylated liposomal doxorubicin hydrochloride
DRUG
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT07388563
NCT06337318
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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