Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
- 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
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
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Joan H. Schiller, MD
University of Wisconsin, Madison
United States: Federal Government
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|