Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Hackensack Meridian Health; Hackensack University Medical Center; M.D. Anderson Cancer Center; National Cancer Institute (NCI); New York University School of Medicine; NYU Langone Health; Roswell Park Cancer Institute; Tibotec Pharmaceutical Limited
• Treatments: Bexarotene; Doxorubicin; Liposomal doxorubicin

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