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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006099 |
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 |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer |
Study Start Date: | May 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Chaitanya R. Divgi, MD | Memorial Sloan-Kettering Cancer Center |
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 |
ovarian epithelial cancer |
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 |
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 |