Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed

Eastern Cooperative Oncology Group

Overview

RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.

OBJECTIVES: * 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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

Ad5CMV-p53 geneBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (3)

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

CCOP - Green Bay

Green Bay, Wisconsin, United States

Data from ClinicalTrials.gov

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