Leukemia Clinical Trial
Official title:
A Phase I Study Of Cloretazine™ (VNP40101M) And Temozolomide In Patients With Hematologic Malignancies
RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Temozolomide may also help VNP40101M kill more cancer cells by making cancer
cells more sensitive to the drug. Giving temozolomide together with VNP40101M may kill more
cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide and
VNP40101M in treating patients with relapsed or refractory leukemias.
OBJECTIVES:
- 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
toxicity.
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
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