Spots Global Cancer Trial Database for VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
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Trial Identification
Brief Title: VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
Official Title: A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
Study ID: NCT00282022
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Contact Details
Name: Bonny L. Johnson, RN, MSN
Affiliation: Vion Pharmaceuticals
Role:
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