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Brief Title: Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
Official Title: A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
Study ID: NCT00005786
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mount Sinai Medical Center, New York, New York, United States
Name: Luis Isola
Affiliation: Icahn School of Medicine at Mount Sinai
Role: PRINCIPAL_INVESTIGATOR