Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I and Pharmacodynamic Study of SB-715992 in Acute Leukemias
Phase I trial to study the effectiveness of SB-715992 in treating patients who have acute leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of SB-715992 given as a daily x 3 infusion
in patients with acute leukemia.
II. To obtain pharmacokinetic studies of SB-715992 given on a 3 consecutive day schedule
every 3 weeks.
III. To describe treatment-related and dose-limiting toxicities of SB-715992 in patients
with acute leukemia.
IV. To describe the anti-leukemia activity of SB-715992. V. To correlate treatment-related
toxicities with pharmacokinetic studies of SB-715992.
SECONDARY OBJECTIVES:
I. To validate KSP as the major target of SB-715992 by determining the impact of drug
treatment on cytoskeletal morphology in peripheral blood mononuclear cells and circulating
leukemic blasts.
II. To determine the expression of tubulin isoforms and KSP in leukemic blasts and explore
possible relationships between gene expression and response to SB-715992.
OUTLINE: This is a dose-escalation, multicenter study.
Induction chemotherapy: Patients receive SB-715992 IV over 1 hour on days 1-3. Treatment
repeats every 21 days for up to 3 courses in the absence of disease progression or
unacceptable toxicity.
Consolidation chemotherapy: Patients achieving complete response (CR), partial response
(PR), or stable disease (SD) after induction chemotherapy receive up to 4 additional courses
of SB-715992 beyond CR, PR, or SD.
Cohorts of 3-6 patients receive SB-715992 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. At least 9 patients are treated at the MTD.
Patients are followed for 6 weeks.
PROJECTED ACCRUAL: Approximately 15-30 patients will be accrued for this study within 7.5-15
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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