Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01212367
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2010-09-29
Brief Title:
Intrapleural Gene Transfer for Pleural Mesothelioma
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha SCH 721015 AdhIFN-a2b Gene Transfer for Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2015-09
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:
IFN-alpha
Brief Summary:
This research will study how to activate the immune system by using gene transfer Gene transfer involves inserting a specially designed gene into cancer cells A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds proteins important for the makeup or function of the cell The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer
Detailed Description:
AdhIFN-α SCH 721015 adenoviral-mediated interferon alpha is a replication-defective recombinant adenoviral vector containing the human interferon-alpha hIFN-alpha gene This Phase I study is designed to evaluate the safety and maximum tolerated dose MTD of two doses of AdhIFN-alpha injected into the pleural intrapleural IP and given 4 days apart in subjects with pleural mesothelioma
Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation Subjects are then followed-up as outpatients for a total of 6 months Radiographic evaluations are repeated on Day 64 and at 6 months The pleural catheter is removed once it is not necessary
Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation Subjects are then followed-up as outpatients for a total of 6 months Radiographic evaluations are repeated on Day 64 and at 6 months The pleural catheter is removed once it is not necessary
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 |