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

NCT ID: NCT00255801

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2017-10-31

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Targretin® (bexarotene)

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Interventions

Targretin® (bexarotene)

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Tibotec Pharmaceutical Limited

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J. Straus, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Steven M. Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Patricia L. Myskowski, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

References

Straus DJ, Duvic M, Horwitz SM, Hymes K, Goy A, Hernandez-Ilizaliturri FJ, Feldman T, Wegner B, Myskowski PL. Final results of phase II trial of doxorubicin HCl liposome injection followed by bexarotene in advanced cutaneous T-cell lymphoma. Ann Oncol. 2014 Jan;25(1):206-10. doi: 10.1093/annonc/mdt480. Epub 2013 Nov 26.

Reference Type: DERIVED

PMID: 24285015 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

MSKCC-05098

Identifier Type: -

Identifier Source: secondary_id

05-098

Identifier Type: -

Identifier Source: org_study_id