|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Unither Pharmaceuticals |
|---|---|
| Information provided by: | Unither Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034372 |
Purpose
In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.
Group 1 will receive two doses, one month apart.
Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses.
Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses.
The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms |
Drug: oregovomab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Gynecologic Oncology Associates | |
| Newport Beach, California, United States, 92663 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Walt Disney Memorial Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| United States, Indiana | |
| St. Joseph's Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Parker Hill Oncology & Hematology | |
| Boston, Massachusetts, United States, 02120 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, Tennessee | |
| Baptist Hospital of East Tennessee | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Texas Oncology, P.A. | |
| Dallas, Texas, United States, 75246 | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Swedish Medical Center Tumor Institute | |
| Seattle, Washington, United States, 98104 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, Manitoba | |
| Cancer Care Manitoba | |
| Winnipeg, Manitoba, Canada, R3E O9V | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Canada, Quebec | |
| Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| SMBD Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
More Information
| Study ID Numbers: | OVA-Gy-15 |
| Study First Received: | April 26, 2002 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00034372 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
immunotherapy monoclonal antibody Stage III ovarian epithelial cancer Stage IV ovarian epithelial cancer |
|
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 |