Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004225
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2000-01-28
Brief Title:
Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting the gene for p53 into a persons cancer cells may improve the bodys 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
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 lesions
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 lesions 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
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 lesions
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 lesions 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-8597 | None | None | None |