Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007826
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-01-06
Brief Title:
Monoclonal Antibody Therapy andor Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Sponsor:
Onyvax
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum
Status:
UNKNOWN
Status Verified Date:
2005-02
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 Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy andor vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy andor vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of monoclonal antibody 105AD7 anti-idiotypic vaccine and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines in patients with locally advanced or metastatic adenocarcinoma of the colon or rectum
Determine any immunological response to these treatment regimens in these patients
Determine the 6-month and 1-year survival of these patients after receiving these treatment regimens
Determine the tumor response to these treatment regimens in these patients
OUTLINE This is an open-label study Patients are assigned to one of three treatment arms
Arm I Patients receive monoclonal antibody 105AD7 anti-idiotype vaccine MOAB 105AD7 plus BCG intradermally ID weekly for weeks 1 and 2 MOAB 105AD7 ID plus alum adjuvant intramuscularly IM weekly for weeks 4 and 6 and then MOAB 105AD7 ID alone monthly for up to 12 months
Arm II Patients receive ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines plus BCG ID weekly for weeks 1 and 2 these vaccines ID weekly for weeks 4 and 6 and then monthly for up to 12 months
Arm III Patients receive MOAB 105AD7 ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines and BCG ID weekly for weeks 1 and 2 MOAB 105AD7 and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines ID plus alum adjuvant IM weekly for weeks 4 and 6 and then MOAB 105AD7 and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines monthly for up to 12 months
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 45 patients 15 per treatment arm will be accrued for this study
Determine the safety and tolerability of monoclonal antibody 105AD7 anti-idiotypic vaccine and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines in patients with locally advanced or metastatic adenocarcinoma of the colon or rectum
Determine any immunological response to these treatment regimens in these patients
Determine the 6-month and 1-year survival of these patients after receiving these treatment regimens
Determine the tumor response to these treatment regimens in these patients
OUTLINE This is an open-label study Patients are assigned to one of three treatment arms
Arm I Patients receive monoclonal antibody 105AD7 anti-idiotype vaccine MOAB 105AD7 plus BCG intradermally ID weekly for weeks 1 and 2 MOAB 105AD7 ID plus alum adjuvant intramuscularly IM weekly for weeks 4 and 6 and then MOAB 105AD7 ID alone monthly for up to 12 months
Arm II Patients receive ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines plus BCG ID weekly for weeks 1 and 2 these vaccines ID weekly for weeks 4 and 6 and then monthly for up to 12 months
Arm III Patients receive MOAB 105AD7 ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines and BCG ID weekly for weeks 1 and 2 MOAB 105AD7 and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines ID plus alum adjuvant IM weekly for weeks 4 and 6 and then MOAB 105AD7 and ONYCR1 ONYCR2 and ONYCR3 allogeneic adenocarcinoma cell-based vaccines monthly for up to 12 months
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 45 patients 15 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1599 | None | None | None |
| ONYVAX-SGCRO01 | None | None | None |