NCT00293280

Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as lomustine, 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 lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene. * Determine whether the response rate in these patients is significantly greater than that of the historical control. Secondary * Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival. Tertiary * Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene. OUTLINE: This is a multicenter study. Patients receive oral lomustine once on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	lomustine

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-07-01
• First posted: 2006-02-17
• Last updated: 2013-05-06

Locations

1 site across 1 country: United States