Non Hodgkin Lymphoma Clinical Trial
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Summary
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.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma
Stage IB-IV disease
Measurable disease
Newly diagnosed or previously treated disease
No demonstrated resistance to prior bexarotene
PATIENT CHARACTERISTICS:
Performance status
Karnofsky 60-100%
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hepatic
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN
Renal
Creatinine ≤ 1.5 times ULN
Cardiovascular
Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
No New York Heart Association class II-IV heart disease
No clinical evidence of congestive heart failure
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
No history of hypersensitivity reactions attributed to doxorubicin HCl liposome or its components
No active potentially life-threatening infection
No other acute disease
PRIOR CONCURRENT THERAPY:
Chemotherapy
See Disease Characteristics
Prior doxorubicin allowed provided the cumulative dose is ≤ 300 mg/m^2
Prior epirubicin hydrochloride allowed provided the cumulative dose is ≤ 540 mg/m^2
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There are 5 Locations for this study
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10065, United States
Houston Texas, 77030, United States
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