Clinical trial NCT00034372: Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: immunotherapy
monoclonal
antibody
Stage III ovarian epithelial cancer
Stage IV ovarian epithelial cancer
Lead sponsor: Unither Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-04-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Orlando
country: United States
facility: Walt Disney Memorial Cancer Institute
state: Florida
city: South Bend
country: United States
facility: St. Joseph's Regional Medical Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Parker Hill Oncology & Hematology
state: Massachusetts
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Knoxville
country: United States
facility: Baptist Hospital of East Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center Tumor Institute
state: Washington
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Fleurimont
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
Study officials:
References: