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Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer

Phase 1
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer

OBJECTIVES: I. Determine the safety of indium In 111 monoclonal antibody Hu3S193 (In 111
MOAB Hu3S193) given intraperitoneally OR intravenously in patients with ovarian carcinoma.
II. Compare the localization of In 111 MOAB Hu3S193 in ovarian cancer tissue after
intraperitoneal vs intravenous injection. III. Compare the biodistribution and
pharmacokinetics of this drug when administered intraperitoneally vs intravenously in these
patients. IV. Determine the antibody response in these patients to this drug.

OUTLINE: Patients are assigned to 1 of 2 treatment arms on a first come sequential basis.
Arm I: Patients receive indium In 111 monoclonal antibody Hu3S193 (In 111 MOAB Hu3S193)
intraperitoneally over 30 minutes. Arm II: Patients receive In 111 MOAB Hu3S193 IV over 30
minutes. Patients undergo surgical debulking 3-7 days following In 111 MOAB Hu3S193
administration, and biopsy samples are obtained to assess radioactive uptake.
Immunohistochemistry is also performed. Blood samples are obtained to assess serum
radioactivity. Whole body imaging is performed 3 hours after infusion of radiolabeled
monoclonal antibody, on the day of surgery, and at one time point in between. Patients are
followed for 30 days.

PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed ovarian carcinoma Must be scheduled for
surgical evaluation

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life
expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 No coagulation disorders Hepatic: Bilirubin
less than 2.0 mg/dL AST and ALT less than 2.5 times upper limit of normal Renal:
Creatinine less than 2.0 mg/dL Cardiovascular: LVEF greater than 50% No New York Heart
Association class III or IV heart disease No abnormalities on ECG that would preclude
study Pulmonary: FEV1 and FVC greater than 70% predicted No severe debilitating pulmonary
disease Other: No concurrent active infection requiring antibiotic therapy No concurrent
medical problem that would preclude study No prior autoimmune hepatitis or autoimmune
disease No psychiatric, addictive, or other disorder that would preclude consent

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine
therapy: Recovered from prior endocrine therapy Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered Surgery: See Disease Characteristics Other: No concurrent
immunosuppressive therapy during the first 30 days after treatment

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Chaitanya R. Divgi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021