Non Hodgkin Lymphoma Clinical Trial
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
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.
Full 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.
Eligibility 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
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There are 5 Locations for this study
Miami Florida, 33136, United States
New York New York, 10016, United States
New York New York, 10021, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
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