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Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006099
First received: August 3, 2000
Last updated: February 6, 2009
Last verified: June 2002
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on November 25, 2014