Lymphoma Clinical Trial
Official title:
Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients
who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia,
lymphoma, or myeloma.
OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients
with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia,
myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in
patients treated with this regimen. III. Determine the toxic effects of this regimen in
these patients.
OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6
months after complete response vs second relapse or refractory vs prior hematologic disorder
vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs
myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5
consecutive days with 2 days of rest. Treatment continues in the absence of disease
progression until complete response or 90 days is reached. Upon achieving complete response,
treatment is discontinued for 30 days. Patients exhibiting complete response receive a
second 28 day course of consolidation therapy while in remission starting no sooner than 31
days after the end of induction therapy. Patients are followed monthly.
PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of
31 patients per leukemia stratum will be accrued for this study within 18-24 months.
;
Primary Purpose: Treatment
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