A Phase I Study of GTI2040 (NSC 722929; IND 67368) in Combination With High-dose Cytarabine in Refractory or Relapsed Acute Myeloid Leukemia (AML)
I. Determine the maximum tolerated dose and recommended phase II dose of GTI-2040 and
high-dose cytarabine in patients with relapsed or refractory acute myeloid leukemia.
I. Determine the therapeutic response in patients treated with this regimen. II. Determine
the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to age (under
age 60 vs age 60 and over). Patients are assigned to 1 of 2 strata.
Stratum I (under age 60): Patients receive GTI-2040 IV continuously on days 1-6 and
high-dose cytarabine IV over 2 hours twice daily on days 2, 4, and 6.
Stratum II (age 60 and over): Patients receive GTI-2040 IV continuously on days 1-6 and
high-dose cytarabine IV over 4 hours once daily on days 2-6.
In both strata, treatment continues in the absence of unacceptable toxicity.
Cohorts of 3-6 patients per stratum receive escalating doses of GTI-2040 and high-dose
cytarabine 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.
PROJECTED ACCRUAL: A total of 6-51patients will be accrued for this study within 2-16
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Up to day 42
Ohio State University
United States: Food and Drug Administration
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