Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma

Phase 2

Terminated

• 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

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2002-04-26
• Study First Submitted QC: 2002-04-26
• Study First Posted: 2002-04-29
• Status Verified: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-13
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

• 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

Trial Locations

Locations (17)

Gynecologic Oncology Associates; 🇺🇸 Newport Beach, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Walt Disney Memorial Cancer Institute; 🇺🇸 Orlando, Florida, United States

St. Joseph's Regional Medical Center; 🇺🇸 South Bend, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Parker Hill Oncology & Hematology; 🇺🇸 Boston, Massachusetts, United States

Ellis Fischel Cancer Center; 🇺🇸 Columbia, Missouri, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Baptist Hospital of East Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Texas Oncology, P.A.; 🇺🇸 Dallas, Texas, United States

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