Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Tracking Information | |||||||||||||
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First Received Date ICMJE | November 18, 2005 | ||||||||||||
Last Updated Date | January 21, 2011 | ||||||||||||
Start Date ICMJE | November 2005 | ||||||||||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
1-year progression-free survival [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
1-year progression-free survival | ||||||||||||
Change History | Complete list of historical versions of study NCT00255801 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
Complete response rate and partial response rate [ Designated as safety issue: No ] | ||||||||||||
Original Secondary Outcome Measures ICMJE |
Complete response rate and partial response rate | ||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma | ||||||||||||
Official Title ICMJE | Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®) | ||||||||||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 2 | ||||||||||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | ||||||||||||
Intervention ICMJE |
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Study Arm (s) | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
Estimated Enrollment ICMJE | 37 | ||||||||||||
Completion Date | |||||||||||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Chemotherapy
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | United States | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00255801 | ||||||||||||
Other Study ID Numbers ICMJE | CDR0000454838, MSKCC-05098 | ||||||||||||
Has Data Monitoring Committee | |||||||||||||
Responsible Party | David J. Straus, Memorial Sloan-Kettering Cancer Center | ||||||||||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | January 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |