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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: bexarotene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interferon alfa|nan|
|Drug: bexarotene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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