Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00255801 |
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 | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bexarotene Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®) |
Estimated Enrollment: | 37 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma
Newly diagnosed or previously treated disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
United States, New Jersey | |
Hackensack University Medical Center Cancer Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: David J. Straus, MD 212-639-8365 strausd@mskcc.org | |
NYU Cancer Institute at New York University Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Kenneth B. Hymes, MD 212-731-5189 kbh1@nyu.edu | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
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 |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David J. Straus ) |
Study ID Numbers: | CDR0000454838, MSKCC-05098 |
Study First Received: | November 18, 2005 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00255801 History of Changes |
Health Authority: | Unspecified |
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 |
Anticarcinogenic Agents Immunoproliferative Disorders Sezary Syndrome Mycosis Fungoides Doxorubicin Recurrence Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Mycoses |
Lymphatic Diseases Bexarotene Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Anticarcinogenic Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Sezary Syndrome Mycosis Fungoides Antibiotics, Antineoplastic Protective Agents Pharmacologic Actions |
Doxorubicin Lymphatic Diseases Neoplasms Bexarotene Therapeutic Uses Lymphoma, T-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |