Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 4:07 AM
Study NCT ID:
NCT00562003
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2007-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)
Status:
COMPLETED
Status Verified Date:
2011-01
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:
Ad5Delta24RGD
Brief Summary:
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.
Secondary objectives :
* To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
* To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
* To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
Secondary objectives :
* To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
* To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
* To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UAB 0643 | None | None | View |