Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

NCT ID: NCT00030849

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2009-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.

Detailed Description

OBJECTIVES:

• Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa.
• Determine the safety and toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral bexarotene once daily for 8 weeks.

Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity.

Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

bexarotene

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma

• Stage IB, IIA, IIB, III, or IV
• Measurable or assessable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 9 g/dL
• WBC at least 1,500/mm^3
• Platelet count at least 70,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 3 times ULN
• Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study)
• No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction)

Renal:

• Calcium no greater than 11.5 mg/dL
• Creatinine no greater than 2 times ULN

Cardiovascular:

• No myocardial infarction in the past 6 months
• No unstable angina
• No class III or IV congestive heart failure
• No ventricular tachyarrhythmias

Pulmonary:

• No pulmonary infiltrates or clinical pulmonary impairment

Other:

• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy
• No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs
• No uncontrolled thyroid disorder
• No other concurrent serious medical illness that would preclude study
• No infection
• No history of pancreatitis
• No history of neuropsychiatric disorders requiring hospitalization
• No history of autoimmune disease that would pose significant risk
• Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent systemic anticancer chemotherapy

Endocrine therapy:

• No concurrent systemic corticosteroids

Radiotherapy:

• No concurrent localized radiotherapy to target lesions unless considered
• to have shown progressive disease

Surgery:

• Not specified

Other:

• At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug
• At least 30 days since prior participation in any other investigational drug study
• No concurrent systemic anti-psoriatic drugs or therapies
• No concurrent systemic other anticancer drugs or therapies
• No concurrent gemfibrozil
• No other concurrent investigational medication

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David J. Straus, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Straus DJ, Duvic M, Kuzel T, Horwitz S, Demierre MF, Myskowski P, Steckel S. Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma. Cancer. 2007 May 1;109(9):1799-803. doi: 10.1002/cncr.22596.

Reference Type: RESULT

PMID: 17366595 (View on PubMed)

Other Identifiers

MSKCC-01128

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2049

Identifier Type: -

Identifier Source: secondary_id

CDR0000069202

Identifier Type: -

Identifier Source: org_study_id