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

Lymphoma Clinical Trial

Official title:

Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255801
• Other study ID #: 05-098
• Secondary ID: MSKCC-05098
• Status: Completed
• Phase: Phase 2
• Start date: November 2005
• Est. completion date: October 2017

Study information

• Verified date: July 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Targretin® (bexarotene)

• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYU Cancer Institute at New York University Medical Center	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Hackensack Meridian Health, M.D. Anderson Cancer Center, National Cancer Institute (NCI), New York University School of Medicine, Roswell Park Cancer Institute, Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Progression-free Survival	CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT; CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.; CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.; Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as =25% increase in mSWAT skin score and =50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease	3 years
Secondary	Maximum Therapeutic Response	CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT; CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.; CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.; Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as =25% increase in mSWAT skin score and =50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease	2 years

External Links

•   Memorial Sloan Kettering Cancer Center