drugset / Trial / NCT00086632

Study of Ovarex® (Oregovomab) MAb With Front-Line Chemotherapy for Ovarian Cancer Treatment

NCT00086632

Phase 2 Terminated 40 enrolled Unither Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.

Timeline

Start
2004-07
Primary completion
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Oregovomab Monoclonal antibody

Indications