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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer  Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
For Condition: ovarian epithelial cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed ovarian carcinoma - Must be scheduled for surgical evaluation --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 --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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChaitanyaDivgi, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068107; MSKCC-00047,NCI-G00-1828
Study Start Date: May 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006099
Other Ovarian Epithelial Cancer Studies:
1. Screening Women at High Genetic Risk for Ovarian Cancer
2. Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
3. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
4. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
5. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Related Studies:
Other ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
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