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 (   (New York Heart Association - NYHA class >/= 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.