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RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myelogenous leukemia.
- Determine the maximum tolerated dose of flavopiridol in adult (stratum 1) and pediatric (stratum 2) patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast crisis.
- Determine the qualitative and quantitative toxic effects of this drug, in terms of organ specificity, time course, predictability, and reversibility, in these patients.
- Determine, preliminarily, the clinical activity of this drug in these patients.
- Determine the plasma and cellular pharmacokinetics of this drug in these patients.
- Determine the pharmacodynamics of this drug in these patients.
- Correlate drug-induced apoptosis of acute leukemia cells in vitro with clinical response in patients treated with this drug.
- Correlate inflammatory cytokine levels with pharmacokinetics, pharmacodynamics, and laboratory and clinical parameters of treatment in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to age group (adult [≥ 18 years] vs pediatric [1-17 years]).
Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study within 1-24 months.
Primary Purpose: Treatment
Cincinnati Children's Hospital Medical Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:53:44-0400
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