Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory lymphoma or leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory low-grade lymphomas. II. To determine the incidence of complete and partial responses to arsenic trioxide in patients with previously treated low-grade lymphomas. III. To evaluate basic science correlates of arsenic trioxide activity in order to improve our understanding of the mechanism of action for arsenic trioxide in patients with low-grade lymphomas. OUTLINE: This is a nonrandomized, open-label study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding or stable disease may receive 6 additional courses. Patients are followed every 3 months for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Given IV
Correlative studies
Mount Sinai Medical Center
New York, New York, United States
Toxicity as assessed by Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria version 2.0
Time frame: Up to 2 years after completion of study treatment
Incidence of complete and partial response
Time frame: Up to 2 years
Potential surrogate of arsenic trioxide clinical activity
Time frame: From baseline to up to 2 years
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