Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003634
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial Fallopian Tube or Peritoneal Cancer Following Surgery and Chemotherapy
Sponsor:
AltaRex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double-Blind Placebo Controlled Trial of Intravenous OvaRex MAb-B4313 as Post Chemotherapy Consolidation for Ovarian Tubal and Peritoneal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-05
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 It is not yet known whether giving monoclonal antibody therapy is more effective than a placebo in treating patients with ovarian epithelial fallopian tube or peritoneal cancer who have responded to surgery and chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial fallopian tube or peritoneal cancer following surgery and chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial fallopian tube or peritoneal cancer following surgery and chemotherapy
Detailed Description:
OBJECTIVES I Compare the time to disease relapse survival and quality of life of patients with stage III or IV ovarian epithelial tubal or peritoneal adenocarcinoma treated with OvaRex monoclonal antibody B4313 OR placebo following complete clinical response to primary therapy II Determine the safety of this regimen in these patients III Assess the immune response of patients treated with this regimen
OUTLINE This is a randomized study Patients undergo a laparotomy and platinum based chemotherapy prior to randomization Patients are randomized to 1 of 2 treatment arms Arm I Patients receive OvaRex monoclonal antibody B4313 IV on day 0 Treatment continues at 4 8 20 32 44 and 56 weeks and then every 3 months in the absence of disease progression or unacceptable toxicity Arm II Patients receive placebo IV on day 0 Placebo administration continues on the same schedule as in arm I Patients presenting with relapse are provided with second line chemotherapy Quality of life is assessed at the beginning of the study after 2 months and then every 3 months thereafter Patients are followed every 3 months
PROJECTED ACCRUAL A total of 400 patients 200 per arm will be accrued for this study
OUTLINE This is a randomized study Patients undergo a laparotomy and platinum based chemotherapy prior to randomization Patients are randomized to 1 of 2 treatment arms Arm I Patients receive OvaRex monoclonal antibody B4313 IV on day 0 Treatment continues at 4 8 20 32 44 and 56 weeks and then every 3 months in the absence of disease progression or unacceptable toxicity Arm II Patients receive placebo IV on day 0 Placebo administration continues on the same schedule as in arm I Patients presenting with relapse are provided with second line chemotherapy Quality of life is assessed at the beginning of the study after 2 months and then every 3 months thereafter Patients are followed every 3 months
PROJECTED ACCRUAL A total of 400 patients 200 per arm 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 |
|---|---|---|---|
| NCI-V98-1488 | None | None | None |
| ALTAREX-OVA-Gy-07 | None | None | None |
| ALTAREX-961452 | None | None | None |
| ALTAREX-OVA-Gy-06 | None | None | None |