Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004064
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
AltaRex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase IIB Study of the Safety and Efficacy of OVAREX MabB4313 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian fallopian tube or peritoneal cancer
PURPOSE Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the safety of OvaRex monoclonal antibody B4313 in patients with elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary fallopian tube or peritoneum but without other evidence of disease II Determine the time to disease progression overall survival CA 125 levels immune responses and quality of life of these patients treated with this regimen
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive placebo IV during weeks 1 3 5 9 13 25 37 and 49 Arm II Patients receive OvaRex monoclonal antibody B4313 MOAB B4313 IV during weeks 1 3 5 9 13 25 37 and 49 Patients in either treatment arm who have no disease progression after week 49 receive MOAB B4313 once every 12 weeks until week 121 Patients with disease progression after week 49 may receive MOAB B4313 alone in combination with or following chemotherapy Quality of life is assessed during the study
PROJECTED ACCRUAL A total of 102 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive placebo IV during weeks 1 3 5 9 13 25 37 and 49 Arm II Patients receive OvaRex monoclonal antibody B4313 MOAB B4313 IV during weeks 1 3 5 9 13 25 37 and 49 Patients in either treatment arm who have no disease progression after week 49 receive MOAB B4313 once every 12 weeks until week 121 Patients with disease progression after week 49 may receive MOAB B4313 alone in combination with or following chemotherapy Quality of life is assessed during the study
PROJECTED ACCRUAL A total of 102 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OU-08111 | None | None | None |
| ALTAREX-OVA-Gy-10 | None | None | None |