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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00418574

Run by

Menarini Group

People needed

888

Starts

2006-12-01

Expected to finish

2011-06-01

Last updated by the study team

2011-11-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Denver, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Curtis and Elizabeth Anderson Cancer Institute — Savannah, Georgia, United States
• Indiana University Cancer Pavilion — Indianapolis, Indiana, United States
• Harry and Jeanette Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• The Cancer Care Center — St Louis, Missouri, United States
• Women's Cancer Center — Las Vegas, Nevada, United States
• Hackensack University Medical Center, Obstetrics and Gynecology Oncology — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Centre — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• The West Clinic — Memphis, Tennessee, United States
• Algemeen Stedelijk Ziekenhuis Aalst — Aalst, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Universitair Ziekenhuis Gent Medische Oncologie 4B-Z — Ghent, Belgium
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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