Leukemia Clinical Trial
Official title:
A Phase II Study of Oral Topotecan in Children With Relapsed Acute 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 topotecan in treating children who
have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous
leukemia.
OBJECTIVES: I. Determine the response rate of patients with relapsed acute lymphocytic
leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia treated with
oral topotecan. II. Determine the toxic effects and pharmacokinetics of this regimen in
these patients.
OUTLINE: Patients are stratified by disease type (acute lymphocytic leukemia vs acute
myeloid leukemia). Patients receive oral topotecan once daily on days 1-21. Courses repeat
every 28 days in the absence of blasts in the blood, M3 bone marrow, or unacceptable
toxicity. Patients are followed every 6 months until death.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study
within 2 years.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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