Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	ECOG-8597 E8597, NCT00004225

Objectives

1. 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).
2. Determine p53 and p21 expression and induction of apoptosis and necrosis in patients treated with this regimen.
3. Assess any vector incorporation, antitumor response, local control, viral dissemination, and development of adenovirus antibodies in patients treated with this regimen.

Entry Criteria

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

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

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/mm³

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

Expected Enrollment

A total of 10 patients will be accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Joan Schiller, MD, Protocol chair(Contact information may not be current)		Ph: 608-263-5389; 800-622-8922

Registry Information
Official Title		Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
Trial Start Date		2000-01-21
Registered in ClinicalTrials.gov		NCT00004225
Date Submitted to PDQ		1999-12-09
Information Last Verified		2004-04-19
NCI Grant/Contract Number		CA21115

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