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

Stopped early · Phase 1/Phase 2

Conditions studied: Ovarian Neoplasms

In brief

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.

Key facts

Study ID

NCT00034138

Run by

Unither Pharmaceuticals

People needed

24

Starts

2002-03-01

Expected to finish

2007-12-01

Last updated by the study team

2007-12-18

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Women's Cancer Research Foundation — Miami, Florida, United States
• Walt Disney Memorial Cancer Institute — Orlando, Florida, United States
• St. Joseph's Medical Center — South Bend, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Magee-Women's Hospital — Pittsburgh, Pennsylvania, United States
• Baptist Hospital of East Tennessee — Knoxville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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