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A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.
OBJECTIVES: * Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M. * Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse \[progressive disease \> 3 months after responding to first-line chemotherapy\] vs resistant disease \[progressive disease during or ≤ 3 months after first-line chemotherapy\]). Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR. After completion of study treatment, patients are followed periodically for up to 18 months. PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, United States
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Start Date
September 1, 2005
Primary Completion Date
May 1, 2008
Last Updated
November 6, 2013
87
ESTIMATED participants
laromustine
DRUG
Lead Sponsor
Vion Pharmaceuticals
NCT07486219
NCT07336732
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07485114