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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:8/18/2018
Start Date:November 2005
End Date:October 2017

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Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)

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.

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
We found this trial at
5
sites
30 Prospect Avenue
Hackensack, New Jersey 07601
(201) 996-5900
Hackensack University Medical Center Cancer Center The mission of the John Theurer Cancer Center is...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Houston, TX
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160 E 34th St
New York, New York 10016
(212) 731-5001
NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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