Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients (Ad5Delta24RGD)
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|ClinicalTrials.gov Identifier: NCT00562003|
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : January 26, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cancer||Procedure: Tenckhoff Catheter placement Drug: Ad5-delta24RGD||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||June 2010|
- 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'.
- To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD [ Time Frame: 1 month ]
- To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562003
|United States, Alabama|
|UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology|
|Birmingham, Alabama, United States, 35205|
|Principal Investigator:||Ronald D Alvarez, M.D.||The University of Alabama at Birmingham|