Working… Menu

Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003649
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : October 30, 2020
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Ad5CMV-p53 gene Phase 1

Detailed Description:


  • Evaluate the safety of multiple endobronchial treatments with adenovirus p53 bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar cell lung carcinoma.
  • Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients.
  • Evaluate whether transbronchial administration of adenovirus p53 results in improved local tumor control in these patients.

OUTLINE: This is a dose escalation study.

Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and 15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or response without significant toxicity, patients may receive a maximum of 3 courses. Treatment beyond 3 courses must be approved by protocol investigator.

Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients in each cohort are followed for dose limiting toxicity (DLT) for 2 weeks after completion of one course before dose escalation proceeds in subsequent cohorts. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 2 additional patients are entered at the same dose level. If more than 1 of 5 patients experience DLT, the previous dose is the maximum tolerated dose (MTD). An additional 10 patients are treated at the MTD.

Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: There will be 15 patients accrued into this study over 1 year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage
Actual Study Start Date : November 1998
Actual Study Completion Date : June 15, 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed unresectable non-small cell lung cancer with a growth pattern allowing access to the majority of tumor cells via the airway (e.g., bronchioloalveolar or papillary adenocarcinoma)



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks


  • Platelet count greater than 100,000/mm^3
  • Prothrombin time and partial thromboplastin time normal


  • Bilirubin less than 1.5 mg/dL


  • Creatinine less than 1.5 mg/dL


  • No New York Heart Association class III or IV heart disease


  • Room air oxygen saturation greater than 90%
  • FEV1 greater than 1.0 L pCO2 less than 50


  • HIV negative
  • No active systemic viral, bacterial, or fungal infections requiring treatment
  • No concurrent illness requiring hospitalization or intravenous medication
  • Not pregnant or nursing
  • Effective contraception required of all fertile patients


Biologic therapy:

  • No prior adenovirus gene therapy
  • At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered


  • At least 2 weeks since any prior systemic chemotherapy and recovered

Endocrine therapy:

  • Recovered from any prior endocrine therapy


  • Recovered from any prior radiotherapy


  • At least 2 weeks since any surgical procedure requiring anesthesia
  • At least 4 weeks since prior surgical resection of lung tissues


  • No other concurrent therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003649

Layout table for location information
United States, Tennessee
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
Publications of Results:
Carbone DP, Adak S, Schiller J, et al.: Adenovirus p53 administered by bronchoalveolar lavage in patients with bronchioalveolar cell lung carcinoma (BAC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2492, 2003.
Kubba SV, Adak S, Schiller J, et al.: Phase I trial of adenovirus p53 in bronchioalveolar cell lung carcinoma (BAC) administered by bronchioalveolar lavage. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1904, 2000.

Layout table for additonal information Identifier: NCT00003649    
Other Study ID Numbers: CDR0000066741
First Posted: April 30, 2003    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: February 2002
Keywords provided by Eastern Cooperative Oncology Group:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases