A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of VNP40101M in patients with advanced solid
tumors or lymphomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for
up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of
6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Mario Sznol, MD
Study Chair
Vion Pharmaceuticals
United States: Federal Government
CDR0000068919
NCT00025129
March 2001
Name | Location |
---|---|
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Veterans Affairs Medical Center - West Haven | West Haven, Connecticut 06516 |