Clinical Trials Directory

Trials / Terminated

TerminatedNCT00086632

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

An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
40 (planned)
Sponsor
Unither Pharmaceuticals · Industry
Sex
Female
Age
80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGoregovomab

Timeline

Start date
2004-07-01
Completion
2007-12-01
First posted
2004-07-09
Last updated
2007-12-18

Source: ClinicalTrials.gov record NCT00086632. Inclusion in this directory is not an endorsement.