Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00255801|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : October 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Targretin® (bexarotene) Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
- Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell lymphoma treated with doxorubicin HCl liposome followed by bexarotene.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Doxil and Targretin® (bexarotene)
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.
|Drug: Targretin® (bexarotene) Drug: pegylated liposomal doxorubicin hydrochloride|
- 1-year progression-free survival [ Time Frame: 2 years ]
- Complete response rate and partial response rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255801
|United States, New Jersey|
|Hackensack University Medical Center Cancer Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||David J. Straus, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Steven M. Horwitz, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Patricia L. Myskowski, MD||Memorial Sloan Kettering Cancer Center|