Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: 90Y-hu3S193; 111In-hu3S193
Intervention description: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.; Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer

Summary:

      RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive
      tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal
      antibody directly into the abdominal cavity may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody
      therapy directly into the abdominal cavity in treating patients who have advanced ovarian
      epithelial cancer.
    

Eligibility criteria:

        Inclusion Criteria

          1. Histologically confirmed non-mucinous ovarian adenocarcinoma.

          2. Persistent or recurrent intraperitoneal cancer following platinum/taxane-based therapy
             for Stage 3 ovarian cancer.

          3. Patients with residual disease < 2cm will be candidates for this study.

          4. The following laboratory and clinical results within the last 2 weeks prior to study
             day 1:

             Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Serum
             bilirubin ≤ 2.0 mg/dL; Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal
             (ULN); Alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum creatinine ≤2.0 mg/dL; Forced
             expiratory volume (FEV1) ≥60% of predicted; Forced vital capacity (FVC) ≥60% of
             predicted; Diffusion capacity ≥55% of predicted; Left ventricular ejection fraction
             (LVEF) ≥50%;

          5. Karnofsky performance status ≥ 70.

          6. Before any trial-specific procedures or treatment can be performed, the patient or
             legally authorized guardian or representative must give witnessed written informed
             consent for participation in the trial.

          7. Placement of an intra-abdominal catheter at the time of surgery.

        Exclusion Criteria

          1. Active parenchymal disease (i.e., Stage IV International Federation of Gynecology and
             Obstetrics (FIGO) classification).

          2. Presence of symptomatic extra abdominal metastases.

          3. Known central nervous system (CNS) tumor involvement.

          4. Clinically significant heart disease (New York Heart Association Class III or IV).

          5. ECG demonstrating clinically significant arrhythmias or evidence of prior myocardial
             infarction.

          6. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding
             disorders that may limit the amount of antibody they can tolerate or render them
             ineligible for surgery.

          7. Chronic inflammatory bowel disease.

          8. Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior to enrollment.

          9. Pregnancy or lactation.

         10. Patients who are positive for human anti-human antibodies (HAHA) and/or who have
             received a murine monoclonal antibody.