Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299962
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2006-03-03
Brief Title:
Gene Therapy for Pleural Malignancies
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta BG00001 AdhIFN-β for Pleural Malignancies
Status:
COMPLETED
Status Verified Date:
2020-03
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:
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals Eligible subjects will have
malignant pleural mesothelioma or
pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space
malignant pleural mesothelioma or
pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space
Detailed Description:
AdhIFN-β BG00001 is a replication-defective recombinant adenoviral vector containing the human interferon-beta hIFN-β gene This Phase I study is designed to evaluate the safety and maximum tolerated dose MTD of two doses of intrapleural IP AdhIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma
Five dose levels will be studied
Dose levels 1 2 and 3 will be given on Days 1 and 15
Dose levels 4 and 5 will be given on Days 1 and 8
Five dose levels will be studied
Dose levels 1 2 and 3 will be given on Days 1 and 15
Dose levels 4 and 5 will be given on Days 1 and 8
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 |
|---|---|---|---|
| P01CA066726 | NIH | None | httpsreporternihgovquickSearchP01CA066726 |