VNP40101M in Treating Patients With Advanced or Metastatic Cancer
- Conditions
- LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00049699
- 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 or metastatic cancer.
- Detailed Description
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.
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
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - West Haven
🇺🇸West Haven, Connecticut, United States