Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-year progression-free survival
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
David J. Straus, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
05-098
NCT ID:
NCT00255801
Start Date:
November 2005
Completion Date:
September 2013
Related Keywords:
- Lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
