Status:
COMPLETED
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Tibotec Pharmaceutical Limited
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 div...
Detailed 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 * Deter...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00255801
Start Date
November 1 2005
End Date
October 1 2017
Last Update
August 16 2018
Active Locations (5)
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1
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
3
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065