Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population. OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy. Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse. PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Given IV
Cancer and Leukemia Group B
Chicago, Illinois, United States
Remission rate (complete and partial remission)
Time frame: Up to 2 years
Remission duration
Remission duration will be estimated using the method of Kaplan Meier.
Time frame: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years
Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 2 years
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