VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Study Completion Date :||May 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|