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

This study has been terminated.
(closed by sponser)
Sponsor:
Information provided by:
Unither Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034372
First received: April 26, 2002
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: oregovomab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Unither Pharmaceuticals:

Estimated Enrollment: 102
Study Start Date: September 2000
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034372

Locations
United States, California
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States, 32804
United States, Indiana
St. Joseph's Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Parker Hill Oncology & Hematology
Boston, Massachusetts, United States, 02120
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Tennessee
Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Washington
Swedish Medical Center Tumor Institute
Seattle, Washington, United States, 98104
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E O9V
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
SMBD Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Unither Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034372     History of Changes
Other Study ID Numbers: OVA-Gy-15
Study First Received: April 26, 2002
Last Updated: December 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Unither Pharmaceuticals:
immunotherapy
monoclonal
antibody
Stage III ovarian epithelial cancer
Stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 17, 2014