NCT00003649

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

Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ad5CMV-p53 gene

Timeline

• Start date: 1998-11-17
• Completion: 2007-06-15
• First posted: 2003-04-30
• Last updated: 2023-06-22

Locations

3 sites across 1 country: United States