Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates
- Determine the activity of irinotecan and cytarabine in patients with refractory or
recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the maximum tolerated dose of irinotecan in this regimen in these patients.
- Correlate the clinical activity of this drug with cellular endpoints associated with
DNA synthesis inhibition, DNA repair, induction of apoptosis, and drug resistance in
OUTLINE: This is a dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days
1-6. Courses repeat every 4 weeks in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. An additional 9 patients with
refractory/relapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia
in myeloid blast transformation are treated at the MTD.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 2.5 years.
Primary Purpose: Treatment
Maria R. Baer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|