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Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Ovarian Neoplasms

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Trial Information

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.

Inclusion Criteria:

- Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal

- 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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

December 2007

Related Keywords:

  • Ovarian Neoplasms
  • immunotherapy
  • monoclonal
  • antibody
  • Stage III ovarian epithelial cancer
  • Stage IV ovarian epithelial cancer
  • Neoplasms
  • Ovarian Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Walt Disney Memorial Cancer Institute Orlando, Florida  32803
Women's Cancer Research Foundation Miami, Florida  33143
St. Joseph's Medical Center South Bend, Indiana  46634
Magee-Women's Hospital Pittsburgh, Pennsylvania  15213
Baptist Hospital of East Tennessee Knoxville, Tennessee  37920
Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506