Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
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|ClinicalTrials.gov Identifier: NCT00003649|
Recruitment Status : Completed
First Posted : April 30, 2003
Last Update Posted : October 30, 2020
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
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): NCT00003649
|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|
|Study Chair:||David P. Carbone, MD, PhD||Vanderbilt-Ingram Cancer Center|