This study evaluates a gene therapy (Ad5CMV-p53) in patients with non-small cell lung cancer that cannot be surgically removed. It included adults over 18 in adequate general condition. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * 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) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Prothrombin time and partial thromboplastin time normal Hepatic: * Bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * Room air oxygen saturation greater than 90% * FEV1 greater than 1.0 L pCO2 less than 50 Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior adenovirus gene therapy * At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered Chemotherapy: * At least 2 weeks since any prior systemic chemotherapy and recovered Endocrine therapy: * Recovered from any prior endocrine therapy Radiotherapy: * Recovered from any prior radiotherapy Surgery: * At least 2 weeks since any surgical procedure requiring anesthesia * At least 4 weeks since prior surgical resection of lung tissues Other: * No other concurrent therapy