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Sponsored by: |
Unither Pharmaceuticals |
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Information provided by: | Unither Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00086632 |
An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: oregovomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment |
Official Title: | An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin |
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | OVA-Gy-18 |
Study First Received: | July 7, 2004 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00086632 |
Health Authority: | United States: Food and Drug Administration |
oregovomab ovarex ovarian cancer |
ovary ovarian carcinoma front-line |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian epithelial cancer Endocrine Gland Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Adnexal Diseases |