A Phase I Study Of Cloretazine™ (VNP40101M) And Temozolomide In Patients With Hematologic Malignancies
- Determine the maximum tolerated dose of temozolomide and VNP40101M in patients with
relapsed or refractory leukemias.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral temozolomide twice daily on days 1-3 (for 5 doses) followed by
VNP401010M IV over 15-60 minutes on day 3 (course 1). Patients achieving a complete or
partial response or having ≥ 50% reduction in bone marrow blasts may receive a second course
of therapy no earlier than day 43. Courses may be repeated approximately every 6 weeks at
the discretion of the sponsor and in the absence of disease progression or unacceptable
Cohorts of 6 patients receive escalating doses of temozolomide until a dose that depletes
leukemic blast AGT in at least 4 of 6 patients is determined. Once this dose is determined,
cohorts of 3-6 patients receive escalating doses of VNP401010M 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 are treated at the MTD.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Bonny L. Johnson, RN, MSN
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|American Health Network - North Illinois Street||Indianapolis, Indiana 46202|