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

Phase 1
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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.

Inclusion Criteria


- Histologically confirmed unresectable non-small cell lung cancer with a growth
pattern allowing access to the majority of tumor cells via the airway (e.g.,
bronchioloalveolar or papillary adenocarcinoma)



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 12 weeks


- Platelet count greater than 100,000/mm^3

- Prothrombin time and partial thromboplastin time normal


- Bilirubin less than 1.5 mg/dL


- Creatinine less than 1.5 mg/dL


- No New York Heart Association class III or IV heart disease


- Room air oxygen saturation greater than 90%

- FEV1 greater than 1.0 L pCO2 less than 50


- HIV negative

- No active systemic viral, bacterial, or fungal infections requiring treatment

- No concurrent illness requiring hospitalization or intravenous medication

- Not pregnant or nursing

- Effective contraception required of all fertile patients


Biologic therapy:

- No prior adenovirus gene therapy

- At least 2 weeks since any systemic biologic therapy including prior biologic
response modifiers and recovered


- At least 2 weeks since any prior systemic chemotherapy and recovered

Endocrine therapy:

- Recovered from any prior endocrine therapy


- Recovered from any prior radiotherapy


- At least 2 weeks since any surgical procedure requiring anesthesia

- At least 4 weeks since prior surgical resection of lung tissues


- No other concurrent therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David P. Carbone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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