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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Targretin® (bexarotene); Drug: pegylated liposomal doxorubicin hydrochloride

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00255801

MSKCC-05098

05-098

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

37 participants in 1 patient group

Doxil and Targretin® (bexarotene)

Experimental group

Description:

Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.

Treatment:

Drug: pegylated liposomal doxorubicin hydrochloride

Drug: Targretin® (bexarotene)