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Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
This study has been completed.
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006099
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

Giving monoclonal antibodies in different ways may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Other: immunohistochemistry staining method
Procedure: biopsy
Procedure: immunoscintigraphy
Radiation: indium In 111 monoclonal antibody Hu3S193
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Indium in 111 oxyquinoline Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic
Official Title: Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006099

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Chaitanya R. Divgi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068107, MSKCC-00047, NCI-G00-1828
Study First Received: August 3, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006099     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer

Study placed in the following topic categories:
Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Genital Diseases, Female
Antibodies, Monoclonal
Antibodies
Ovarian Cancer
Endocrinopathy
Immunoglobulins
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Antibodies, Monoclonal
Neoplasms
Antibodies
Neoplasms by Site
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009