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Sponsors and Collaborators: |
University of Alabama at Birmingham National Cancer Institute (NCI) |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00562003 |
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 :
Condition | Intervention | Phase |
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Ovarian Cancer Primary Peritoneal Cancer |
Procedure: Tenckhoff Catheter placement Drug: Ad5-delta24RGD |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 42 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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'.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
Exclusion Criteria:
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 |
Responsible Party: | UAB ( Ronald D. Alvarez, MD / Director,Division of Gynecologic Oncology ) |
Study ID Numbers: | F061005016 (UAB 0643), UAB 0643 |
Study First Received: | November 20, 2007 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00562003 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ovarian cancer study |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Adenoviridae Infections Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |