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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ad5CMV-p53 gene
radiation therapy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
July 3, 2010
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004225
Brief Title
Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Official Title
Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Ad5CMV-p53 gene
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan H. Schiller, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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