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

May 3, 2013 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Julie Brahmer, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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