VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
|ClinicalTrials.gov Identifier: NCT00025129|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: laromustine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer|
|Study Start Date :||March 2001|
|Study Completion Date :||May 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025129
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|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|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|