Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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