NCT00025129

VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	laromustine

Timeline

• Start date: 2001-03-01
• Completion: 2004-05-01
• First posted: 2003-01-27
• Last updated: 2013-07-18

Locations

3 sites across 1 country: United States