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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lomustine
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Toxicity
Disease stabilization
Time to disease progression
Overall survival
Association between clinical outcome and immunohistochemical staining

Full Information

First Posted
February 16, 2006
Last Updated
May 3, 2013
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00293280
Brief Title
Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lomustine
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
Toxicity
Title
Disease stabilization
Title
Time to disease progression
Title
Overall survival
Title
Association between clinical outcome and immunohistochemical staining

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Brahmer, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

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

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