Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients

Inclusion Criteria:

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 Bilirubin Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Exclusion Criteria:

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.