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

NCT ID: NCT00034372

Last Updated: 2007-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2007-12-31

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.

Conditions

Ovarian Neoplasms

Keywords

immunotherapy; monoclonal; antibody; Stage III ovarian epithelial cancer; Stage IV ovarian epithelial cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oregovomab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and disease is classified as FIGO Stage III or IV.
• Functional Performance Status < or = 2 by ECOG scale or > or = 60% on Karnofsky scale.
• Medical assessment consistent with prognosis for an expected survival of at least 6 months.
• Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL and immunohistochemical evidence of tumor tissue expressing CA125.
• Presence of residual disease that is either (a) visible to or palpable by the surgeon at the completion of the staging laparotomy procedure, or (b) microscopic disease remaining following the staging laparotomy procedure.
• Received chemotherapy that included cisplatin or carboplatin following appropriate staging procedure.
• Complete clinical response to primary treatment protocol, which included laparotomy followed by platinum-based adjuvant chemotherapy.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Unither Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

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

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Swedish Medical Center Tumor Institute

Seattle, Washington, United States

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

Fleurimont, Quebec, Canada

SMBD Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

OVA-Gy-15

Identifier Type: -

Identifier Source: org_study_id