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| ID | Type | Description | Link |
|---|---|---|---|
| UAB 0643 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenckhoff Catheter placement | Procedure | 'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department. | ||
| Ad5-delta24RGD | Drug | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD | 1 month |
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Inclusion Criteria:
Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
Patients must be 19 years or older (as mandated by Alabama state law) and must have signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald D Alvarez, M.D. | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology | Birmingham | Alabama | 35205 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |