Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003649
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma BAC Administered by Bronchoalveolar Lavage
Status:
COMPLETED
Status Verified Date:
2023-06
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 Exposing tumor cells to the p53 gene may improve the bodys 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
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
Detailed Description:
OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-6597 | None | None | None |