- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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 therapy
- Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction
- Bidimensionally measurable or evaluable disease
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Overall survival
|
Time to disease progression
|
Disease stabilization
|
Association between clinical outcome and immunohistochemical staining
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Julie Brahmer, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Lomustine
Other Study ID Numbers
- JHOC-J0336, CDR0000452787
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-J0336
- WIRB-20031229
- WCCC-CO-00501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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