NCT00034372

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
2 countries

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2002

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

April 26, 2002

Last Update Submit

December 13, 2007

Conditions

Ovarian Neoplasms

Keywords

immunotherapymonoclonalantibodyStage III ovarian epithelial cancerStage IV ovarian epithelial cancer

Interventions

oregovomabDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Walt Disney Memorial Cancer Institute

Orlando, Florida, 32804, United States

Location

St. Joseph's Regional Medical Center

South Bend, Indiana, 46617, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Parker Hill Oncology & Hematology

Boston, Massachusetts, 02120, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37920, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Swedish Medical Center Tumor Institute

Seattle, Washington, 98104, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E O9V, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

oregovomab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2002

First Posted

April 29, 2002

Study Start

September 1, 2000

Study Completion

December 1, 2007

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

US(12)CA(5)