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

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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.

Inclusion Criteria


- Histologically confirmed non-small cell bronchogenic carcinoma, including the
following histologic subtypes:

- Squamous cell

- Adenocarcinoma

- Adenosquamous

- Large cell anaplastic

- Bronchoalveolar

- Non-small cell carcinoma not otherwise specified (NOS)

- Stage IIIB disease (with a pleural effusion) or stage IV disease

- Stage IV patients with brain metastases are eligible provided the brain
metastases are clinically stable after treatment with surgery and/or radiation

- Tumors must test positive for aberrant methylation of the MGMT gene by
methylation-specific polymerase chain reaction

- Bidimensionally measurable or evaluable disease


- ECOG performance status 0-2

- No other active malignancies

- WBC ≥ 4,000/mm^3 OR absolute neutrophil count ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin normal

- AST < 5 times upper limit of normal

- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

- No uncontrolled serious active infection

- Not pregnant or nursing


- See Disease Characteristics

- More than 3 weeks since prior chemotherapy

- No more than 2 prior chemotherapy regimens

- No prior therapy with nitrosoureas

- Recovered from prior radiation therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Julie Brahmer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

JHOC-J0336, CDR0000452787



Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410