Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma
- Conditions
- Ovarian Neoplasms
- Registration Number
- NCT00034372
- Lead Sponsor
- Unither Pharmaceuticals
- Brief Summary
In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.
Group 1 will receive two doses, one month apart.
Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses.
Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses.
The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 102
Not provided
- First dose of study medication must be within 10 weeks of completing last dose of primary chemotherapy.
- Not more than one prior regimen of chemotherapy. A change of chemotherapy agents is permitted during the patient's primary therapy provided that the change is considered to be part of the initial chemotherapy treatment regimen.
- No whole abdomen, abdominopelvic or pelvic radiotherapy, surgery or chemotherapy within 4 weeks prior to first dose of study drug.
- No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 6 weeks of first study dose. Patients who have received hemopoietic factors are acceptable.
- No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes.
- No compromised hematopoietic function defined as a hemoglobin <8.0 g/dL or lymphocyte count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3.
- No hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits.
- No severe renal dysfunction defined as serum creatinine >1.6 mg/dL.
- While pregnancy is unlikely in view of the disease and previous surgery, patients who the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method. Patients who are breast-feeding are also excluded.
- No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn?s Disease, MS, ankylosing spondylitis).
- No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug.
- Not on chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
- No active infection causing fever.
- No previous splenectomy.
- No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies.
- No uncontrolled diseases or illness other than this cancer. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
- No significant cardiovascular abnormalities (uncontrolled hypertension, CHF (NYHA Classes II-IV), uncontrolled angina, or uncontrolled arrhythmias).
- No concurrent illness or chronically taking medication that could confound the results of the study, preclude the patient from completing the study or mask an adverse reaction.
- No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for > or = 5 years.
- No other investigational drugs within 30 days of enrollment.
- No contraindications present to the use of pressor agents.
- Inability to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment.
- Only tumors of low malignant potential or with noninvasive disease.
- Not more than one interval debulking procedure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Parker Hill Oncology & Hematology
🇺🇸Boston, Massachusetts, United States
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Walt Disney Memorial Cancer Institute
🇺🇸Orlando, Florida, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
St. Joseph's Regional Medical Center
🇺🇸South Bend, Indiana, United States
Baptist Hospital of East Tennessee
🇺🇸Knoxville, Tennessee, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Swedish Medical Center Tumor Institute
🇺🇸Seattle, Washington, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Gynecologic Oncology Associates
🇺🇸Newport Beach, California, United States