Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MSKCC-01128 NCI-G01-2049, NCT00030849

Objectives

1. 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.
2. Determine the safety and toxicity in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed cutaneous T-cell lymphoma
  • Stage IB, IIA, IIB, III, or IV



• Measurable or assessable disease

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

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/mm³
• Platelet count at least 70,000/mm³

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

Expected Enrollment

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

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.

Straus DJ, Duvic M, Kuzel T, et al.: 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 109 (9): 1799-803, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

David Straus, MD, Protocol chair		Ph: 212-639-8365; 800-525-2225 Email: strausd@mskcc.org

Registry Information
Official Title		Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
Trial Start Date		2001-10-09
Registered in ClinicalTrials.gov		NCT00030849
Date Submitted to PDQ		2001-12-27
Information Last Verified		2004-10-18
NCI Grant/Contract Number		P30-CA08748

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