Education and Training
Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Placebo
- biological: Abagovomab
Eligibility
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 = 1.5 * ULN (Upper Limit of Normal);
- Bilirubin = 1.5 * ULN; AST, ALT, AP = 2.5 * ULN.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2.
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 (= 6 months) or decompensated heart failure
(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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Fitzsimmons Colleen
6507243155
Not Recruiting