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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 26, 2002 |
| Last Updated Date | December 13, 2007 |
| Start Date ICMJE | September 2000 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00034372 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma |
| Official Title ICMJE | |
| Brief Summary | In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration. Group 1 will receive two doses, one month apart. Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses. Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses. The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Ovarian Neoplasms |
| Intervention ICMJE | Drug: oregovomab |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | 102 |
| Completion Date | December 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
|
| 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, Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00034372 |
| Responsible Party | |
| Study ID Numbers ICMJE | OVA-Gy-15 |
| Study Sponsor ICMJE | Unither Pharmaceuticals |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Unither Pharmaceuticals |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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