Leukemia Clinical Trial
Official title:
Arsenic Trioxide Therapy for Interferon Alpha Refractory or Intolerant Chronic Phase Chronic Myelogenous 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 chronic phase chronic myelogenous leukemia that has not responded to previous
treatment.
OBJECTIVES:
I. Determine the rate of complete or major cytogenetic response to arsenic trioxide as
demonstrated by a decrease in the percentage of Philadelphia chromosome positive (or
breakpoint cluster region bcr positive) cells in the bone marrow in patients with interferon
alfa refractory or intolerant chronic phase chronic myelogenous leukemia.
II. Determine the rate and duration of complete hematological response to this treatment in
these patients.
III. Determine the duration of complete and major cytogenetic response to this treatment in
these patients.
IV. Determine the pattern of clinical adverse experience and improvement in symptomatic
parameters with this treatment in these patients.
V. Determine the time to accelerated disease or blast crisis and overall survival in these
patients after receiving this treatment.
VI. Determine the effects of this treatment on cytokines, apoptosis, and angiogenesis in
these patients.
OUTLINE: Patients receive arsenic trioxide intravenous (IV) over 2 hours either daily for 15
consecutive days or 5 days on, 2 days off for a total of 15 doses. Treatment repeats every
2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease
progression or unacceptable toxicity. Patients achieving complete remission are followed
every month for 3 months, every 2 months for 6 months, every 3-4 months for 1 year, and then
every 6 months thereafter. All other patients are followed every 3 months for 1 year and then
annually thereafter.
PROJECTED ACCRUAL: A total of 17-53 patients will be accrued for this study within 2.5 years.
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