Adenoviral-mediated p53 gene transfer to non-small cell lung cancer through endobronchial injection

Chest. 2000 Oct;118(4):966-70. doi: 10.1378/chest.118.4.966.


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 Oncology, 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 10(6) to 1 x 10(11) plaque-forming units) was 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adenoviruses, Human / genetics
  • Aged
  • Antineoplastic Agents / therapeutic use
  • Bronchoscopy
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / genetics
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Cisplatin / therapeutic use
  • Disease Progression
  • Drug Therapy, Combination
  • Female
  • Gene Transfer Techniques*
  • Genes, p53 / genetics*
  • Genetic Therapy*
  • Genetic Vectors / administration & dosage*
  • Humans
  • Injections, Intralesional
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / genetics
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Safety


  • Antineoplastic Agents
  • Cisplatin