Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
- 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.
- Collect preliminary data on toxicity, disease stabilization, time to disease
progression, and overall survival.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Julie Brahmer, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|