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

December 13, 2007 updated by: Unither Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unither Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 26, 2002

First Submitted That Met QC Criteria

April 26, 2002

First Posted (Estimate)

April 29, 2002

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVA-Gy-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Neoplasms

Clinical Trials on oregovomab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe