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Sponsored by: |
Unither Pharmaceuticals |
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Information provided by: | Unither Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00034372 |
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 |
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Ovarian Neoplasms |
Drug: oregovomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
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 |
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 |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer |
Carcinoma Genital Diseases, Female Antibodies Ovarian Cancer Endocrinopathy Immunoglobulins 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 |