RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
OBJECTIVES: Primary * Determine the maximum tolerated dose of clofarabine in patients with relapsed or refractory T-cell or natural killer-cell lymphoma. * Determine the toxicity of this drug in these patients. * Determine, preliminarily, the efficacy of this drug, in terms of response rate, in these patients. OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study. * Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) or complete response (CR) may receive 2 additional courses of treatment. Patients with PR or CR after completing 4 courses of therapy may receive 2 additional courses. Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive clofarabine as in phase I at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Memorial Sloan Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Maximum Tolerated Dose
Time frame: 2 years
Response Rate for Participants With Non-Hodgkin's Lymphoma
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
Time frame: 2 years
Participants Evaluated for Toxicity
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
Time frame: 2 years
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