Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
Trial ID or NCT#
The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.
A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
- At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria: - Age >/= 18 years; - Properly executed written informed consent; - History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; - History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy; - Complete clinical response defined as: - Normal physical examination; - No symptoms suggestive of persistent cancer; - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks; - Negative chest x-ray (or chest CT scan) within the previous 4 weeks; - Serum CA125 within the normal laboratory range. - Adequate hematologic, renal and hepatic function: - Absolute Neutrophil Count (ANC) >/=1.5 * 109/l; - Platelets >/= 75 * 109/l; - Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl); - Serum creatinine
- Patients are ineligible to participate in the study, if any of the following criteria are present: - any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy; - known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.); - known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.); - known infection with hepatitis B, or hepatitis C; - history of recent myocardial infarction (/= III); - previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy. - concomitant use of any other investigational agent; - any prior investigational anti-cancer vaccine or monoclonal antibody; - known allergy to murine proteins; - any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; - clinically significant active infection; - concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.); - major surgery within the previous 2 weeks; - radiotherapy within the previous 4 weeks; - any significant toxicity from prior chemotherapy; - unreliability or inability to follow protocol requirements; - potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period; - pregnancy.
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