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.|
|ClinicalTrials.gov Identifier: NCT00004225|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 7, 2010
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer|
|Study Start Date :||January 2000|
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 ClinicalTrials.gov identifier (NCT number): NCT00004225
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Joan H. Schiller, MD||University of Wisconsin, Madison|