A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia
- Determine the complete response rate to VNP40101M in patients with acute myelogenous
leukemia or high-risk myelodysplasia .
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified to acute
myelogenous leukemia (AML) or high risk myelodysplasia (MDS) patients ≥ 60 years old with no
prior treatment vs AML patients any age in first relapse. (AML patients any age in first
relapse closed to accrual 06/09/05).
Patients receive VNP40101M IV over 30 minutes once on day 1 (course 1).
Four to five weeks after the first course, patients undergo bone marrow aspiration and
biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a
second course of VNP40101M (at the same dose as in course 1). If patients achieve complete
response (CR), or partial CR after the first or second course, a consolidation course may be
given comprising VNP40101M at a reduced dose.
Patients are followed monthly for 6 months, every 2 months for 12 months, and then every 3
months for 18 months .
PROJECTED ACCRUAL: A total of 230 patients (100 with acute myelogenous leukemia (AML) or
high-risk myelodysplasia and 130 with AML in first relapse) will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Complete response rate
Francis J. Giles, MD
M.D. Anderson Cancer Center
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|