NCT00282022

VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer

A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	laromustine

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-05-01
• First posted: 2006-01-25
• Last updated: 2013-11-06

Locations

9 sites across 1 country: United States