Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage
- 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.
Primary Purpose: Treatment
David P. Carbone, MD, PhD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|CCOP - Green Bay||Green Bay, Wisconsin 54301|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus||Nashville, Tennessee 37212|