VNP40101M in Treating 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 or metastatic cancer.
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer|
|Study Start Date:||October 2002|
|Study Completion Date:||January 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049699
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Veterans Affairs Medical Center - West Haven|
|West Haven, Connecticut, United States, 06516|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|