A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
OBJECTIVES:
- Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid
tumor or lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every
28 days.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated
dose is determined.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Mario Sznol, MD
Study Chair
Vion Pharmaceuticals
United States: Federal Government
CDR0000258355
NCT00049699
October 2002
Name | Location |
---|---|
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Veterans Affairs Medical Center - West Haven | West Haven, Connecticut 06516 |