This trial is active, not recruiting.

Condition lymphoma
Treatments targretin® (bexarotene), pegylated liposomal doxorubicin hydrochloride
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date September 2017
Trial size 37 participants
Trial identifier NCT00255801, 05-098, MSKCC-05098


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
targretin® (bexarotene)
pegylated liposomal doxorubicin hydrochloride

Primary Outcomes

1-year progression-free survival
time frame: 2 years

Secondary Outcomes

Complete response rate and partial response rate
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)
Principal investigator David J. Straus, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.