A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).
Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Birmingham, Alabama 35233, United States
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