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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00255801

Purpose

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 2

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Bexarotene

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

1-year progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete response rate and partial response rate [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	November 2005
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255801

Locations

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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David J. Straus, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00255801 History of Changes
Other Study ID Numbers:	CDR0000454838, MSKCC-05098
Study First Received:	November 18, 2005
Last Updated:	January 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

Doxorubicin
Bexarotene
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2012