Leukemia Clinical Trial
Official title:
A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways
to stop cancer cells from dividing so they stop growing or die. Combining more than one drug
may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in
treating patients who have hematologic malignancies, including myelodysplastic syndrome or
relapsed, refractory, or untreated leukemia.
OBJECTIVES:
- 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
the MTD.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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