Leukemia Clinical Trial
Official title:
A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic 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 relapsed or refractory acute lymphoblastic leukemia.
OBJECTIVES:
- Determine the complete remission rate of patients with relapsed or refractory acute
lymphoblastic leukemia treated with arsenic trioxide.
- Determine the toxic effects of induction arsenic trioxide in this patient population.
OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5
days a week vs 7 days a week).
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less
than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving
a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a
week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free
intervals between courses. Treatment continues for a maximum of 5 consolidation courses in
the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
;
Primary Purpose: Treatment
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