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A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia (NCT00003735)

National Cancer Institute (NCI)
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.
  • Drug: topotecan hydrochloride
    given by mouth
    • Hycamptamine
    • SK&B 104864-A
    • 9-dimethylaminomethyl-10-hydroxycamptothecin hydrochloride
    • IND #56, 270.
Ages eligible for Study
up to 21 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.

38 locations

30 November, 1998
22 July, 2014
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