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A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Clinical Research Center
Tucson, Arizona, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, United States
Start Date
March 1, 2001
Completion Date
May 1, 2004
Last Updated
July 18, 2013
laromustine
DRUG
Lead Sponsor
Vion Pharmaceuticals
NCT05529069
NCT06337318
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