Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma

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.

Timeline

Start

2000-09

Primary completion

—

Completion

2007-12

Drugs

Indications