Lung Cancer Clinical Trial

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


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.

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Full Description


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.

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Eligibility 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

Study is for people with:

Lung Cancer


Phase 1

Study ID:


Recruitment Status:



Eastern Cooperative Oncology Group

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There are 3 Locations for this study

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Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
CCOP - Green Bay
Green Bay Wisconsin, 54301, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer


Phase 1

Study ID:


Recruitment Status:



Eastern Cooperative Oncology Group

How clear is this clinincal trial information?


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