VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
- Conditions
- LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00025129
- Lead Sponsor
- Vion Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - West Haven
🇺🇸West Haven, Connecticut, United States