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

Not Recruiting

Trial ID: NCT00418574


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.

Official Title

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

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

   - 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.


biological: Placebo

biological: Abagovomab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Fitzsimmons Colleen

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