Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in treating patients who have non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility and tolerability of adenovirus p53 gene therapy and radiotherapy in patients with non-small cell lung cancer with or without prior radiotherapy to the indicator lesion(s). Determine p53 and p21 expression and induction of apoptosis and necrosis in patients treated with this regimen. Assess any vector incorporation, antitumor response, local control, viral dissemination, and development of adenovirus antibodies in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified by prior radiotherapy to the indicator lesion(s) (yes vs no). Adenovirus p53 is injected directly into an endobronchial lesion via bronchoscopy or into locoregional tumors via multiple percutaneous punctures under fluoroscopic, ultrasonic, or CT scan guidance on days 1, 3, and 8. Patients undergo radiotherapy beginning on day 2 and continuing for a total of 10 days. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 1 year.

Official Title
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Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: Ad5CMV-p53 gene
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer with at least 1 lesion accessible for endobronchial or percutaneous injection Measurable or evaluable disease Must have a requirement for palliative radiotherapy to the thorax Clinically stable enough to undergo 3 adenovirus injections PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 12 weeks Hematopoietic: Platelet count greater than 100,000/mm^3 Hepatic: PT and PTT normal Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active systemic viral, bacterial, or fungal infection requiring treatment No concurrent illness requiring hospitalization or IV medications or psychologic, familial, sociologic, geographic, or other concurrent condition that would preclude adequate follow up and compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior adenoviral gene therapy Any number of any type of other prior biologic therapy allowed Chemotherapy: Any number of any type of prior chemotherapy allowed At least 2 weeks since prior systemic cancer therapy and no worse than grade 2 toxicity in any organ Endocrine therapy: Any number of any type of prior endocrine therapy allowed Radiotherapy: See Disease Characteristics No prior radiotherapy greater than 50 Gy if prior and concurrent radiation fields include the spinal cord No prior radiotherapy in fraction sizes greater than 2 Gy with the spinal cord in the concurrent radiation field Surgery: At least 4 weeks since surgical resection of lung tissue At least 2 weeks since any other prior surgery requiring general anesthesia and recovered

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Ad5CMV-p53 gene|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer