A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients With Ovarian Epithelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034138
Recruitment Status : Terminated (closed by sponser)
First Posted : April 24, 2002
Last Update Posted : December 18, 2007
Information provided by:
Unither Pharmaceuticals

Brief Summary:
The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: oregovomab Phase 1 Phase 2

Detailed Description:

This is a prospective, open-label, randomized, parallel group, Phase 1/2 study in female patients with Stage III/IV epithelial ovarian cancer. The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. The study will also evaluate the safety of the cell culture product and the immune responses in patients following treatment. The study is being conducted in three phases:

  1. The pharmacokinetic assessment phase will include at least 24 patients, who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product.
  2. The treatment phase will continue administration of two more monthly doses (weeks 4 and 8) and all patients will receive cell culture product. Study patients will be followed for safety and immune response through week 20.
  3. The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy. Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2002
Actual Study Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin.
  • FIGO Stage III or IV prior to study.
  • Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL following surgery or immunohistochemical evidence of tumor tissue expressing CA125.
  • Completed primary treatment following initial diagnosis, including chemotherapy involving a cisplatin or carboplatin-based regimen.
  • Functional Performance Status < or = 2 by ECOG scale.
  • Medical assessment consistent with prognosis for an expected survival of at least 3 months.
  • Voluntary participation, signed informed consent and willingness to complete all study procedures.

Exclusion Criteria:

  • No surgery (not including minor surgical procedures), chemotherapy, or radiotherapy (whole abdomen, abdominopelvic or pelvic) within 4 weeks prior to first dose of study drug.
  • No known refractory or recurrent disease requiring chemotherapy during the 4 weeks prior to, or planned 10 weeks after first study dose.
  • Serum CA125 levels not >800 U/mL at baseline evaluation.
  • No gross (clinically evident) ascites.
  • No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 4 weeks of first study dose.
  • No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes or serum human anti-murine antibodies (HAMA) not above upper limit of normal at baseline evaluation.
  • Not on long-term chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
  • Ovarian tumors must be of low malignant potential or with noninvasive disease.
  • 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 known allergy to murine proteins, or prior documented anaphylactic reaction to any drug, or known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
  • No previous splenectomy.
  • No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn's Disease, MS, ankylosing spondylitis).
  • 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.
  • No significant cardiovascular abnormalities including uncontrolled hypertension, uncontrolled angina, uncontrolled arrhythmias, or CHF (NYHA Classes II-IV).
  • No compromised hematopoietic function defined as a hemoglobin <10.0 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 above upper limit of normal, LDH, SGOT and SGPT >2 times upper limits of normal, or albumin <3.5 g/dL.
  • No renal dysfunction defined as serum creatinine above upper limit of normal.
  • No pregnancy or breast-feeding (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.)
  • No other investigational drugs within 30 days of enrollment.
  • No contraindications present to the use of pressor agents.
  • No HIV infection, or recent history of drug abuse, alcoholism, or hepatitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034138

United States, Florida
Women's Cancer Research Foundation
Miami, Florida, United States, 33143
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States, 32804
United States, Indiana
St. Joseph's Medical Center
South Bend, Indiana, United States, 46634
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Pennsylvania
Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Unither Pharmaceuticals Identifier: NCT00034138     History of Changes
Other Study ID Numbers: OVA-Gy-16
First Posted: April 24, 2002    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
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