Trials / Completed
CompletedNCT00562003
Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tenckhoff Catheter placement | 'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department. |
| DRUG | Ad5-delta24RGD | Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed. The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'. |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2009-05-01
- Completion
- 2010-06-01
- First posted
- 2007-11-21
- Last updated
- 2011-01-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00562003. Inclusion in this directory is not an endorsement.