Liposomal Doxorubicin Followed By Bexarotene 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.

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