|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006099 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer | ||||
| Official Title ICMJE | Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer | ||||
| Brief Summary | 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. |
||||
| 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. |
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic | ||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006099 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068107, MSKCC-00047, NCI-G00-1828 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2002 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||