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Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

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: NCT00004225
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 7, 2010
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in treating patients who have non-small cell lung cancer.

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

Detailed Description:


  • Determine the feasibility and tolerability of adenovirus p53 gene therapy and radiotherapy in patients with non-small cell lung cancer with or without prior radiotherapy to the indicator lesion(s).
  • Determine p53 and p21 expression and induction of apoptosis and necrosis in patients treated with this regimen.
  • Assess any vector incorporation, antitumor response, local control, viral dissemination, and development of adenovirus antibodies in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by prior radiotherapy to the indicator lesion(s) (yes vs no).

Adenovirus p53 is injected directly into an endobronchial lesion via bronchoscopy or into locoregional tumors via multiple percutaneous punctures under fluoroscopic, ultrasonic, or CT scan guidance on days 1, 3, and 8. Patients undergo radiotherapy beginning on day 2 and continuing for a total of 10 days.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 1 year.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
Study Start Date : January 2000

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven non-small cell lung cancer with at least 1 lesion accessible for endobronchial or percutaneous injection
  • Measurable or evaluable disease
  • Must have a requirement for palliative radiotherapy to the thorax
  • Clinically stable enough to undergo 3 adenovirus injections



  • 18 and over

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • At least 12 weeks


  • Platelet count greater than 100,000/mm^3


  • PT and PTT normal


  • Not specified


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


  • No active systemic viral, bacterial, or fungal infection requiring treatment
  • No concurrent illness requiring hospitalization or IV medications or psychologic, familial, sociologic, geographic, or other concurrent condition that would preclude adequate follow up and compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative


Biologic therapy:

  • No prior adenoviral gene therapy
  • Any number of any type of other prior biologic therapy allowed


  • Any number of any type of prior chemotherapy allowed
  • At least 2 weeks since prior systemic cancer therapy and no worse than grade 2 toxicity in any organ

Endocrine therapy:

  • Any number of any type of prior endocrine therapy allowed


  • See Disease Characteristics
  • No prior radiotherapy greater than 50 Gy if prior and concurrent radiation fields include the spinal cord
  • No prior radiotherapy in fraction sizes greater than 2 Gy with the spinal cord in the concurrent radiation field


  • At least 4 weeks since surgical resection of lung tissue
  • At least 2 weeks since any other prior surgery requiring general anesthesia and recovered

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): NCT00004225

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United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Joan H. Schiller, MD University of Wisconsin, Madison
Layout table for additonal information Identifier: NCT00004225    
Other Study ID Numbers: CDR0000067466
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases