Abstract
Objective: The objective was to determine the degree of toxicity and antitumor activity following bronchoscopic injection of an adenoviral-mediated p53 gene (Adp53) into tumors causing airway obstruction. Dosing: This was a subset analysis of a phase I dose escalation trial. Setting: Patients were treated in the outpatient clinics at the University of Texas (MD Anderson Cancer Center, Houston, TX) and at Medical City Dallas Hospital (US Ontology, Dallas, TX). Patients: Twelve patients (median age, 60 years) with advanced endobronchial non-small cell lung cancer (NSCLC) (squamous cell carcinoma, six patients; adenocarcinoma, six patients) were entered into trial. The median tumor area was 5 x 3.2 cm. All patient tumors contained a p53 gene mutation. Interventions: Adp53 (dose range, 1 x 106 to 1 x 1011 plaque-forming units) as administered by bronchoscopic intratumoral injection once every 28 days. Measurements and results: Toxicity attributed to the Adp53 vector was minimal. Six of the 12 patients had significant improvement in airway obstruction, and 3 patients met the criteria for partial response. Conclusions: Direct bronchoscopic injection of Adp53 into endobronchial NSCLC is safe, with acceptable levels of toxicity. The initial clinical results demonstrating relief of airway obstruction warrant further clinical investigation.
Original language | English (US) |
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Pages (from-to) | 966-970 |
Number of pages | 5 |
Journal | Chest |
Volume | 118 |
Issue number | 4 |
DOIs | |
State | Published - 2000 |
Keywords
- Adenovirus
- Lung cancer
- p53
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Critical Care and Intensive Care Medicine
- Cardiology and Cardiovascular Medicine