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| Sponsored by: |
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 |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Oregovomab |
| 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 | |||||
| Unither Pharmaceuticals |
More Information
| Study ID Numbers: | OVA-Gy-15 |
| First Received: | April 26, 2002 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00034372 |
| Health Authority: | United States: Food and Drug Administration |
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