A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
- Determine the maximum tolerated dose of VP40101M when administered with cytarabine in
patients with hematologic malignancies.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of VNP40101M.
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age
OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV
over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in
patients with responding disease) in the absence of disease progression or unacceptable
toxicity. Patients with a continued response may receive additional courses at the
discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of VNP40101M 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. Up to 10 patients may receive treatment at
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|