Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033748
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2002-04-09
Brief Title:
Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
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 Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver
Detailed Description:
OBJECTIVES
Primary
Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Beginning 6-12 weeks after curative hepatic resection patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1 15 29 and 45 then subcutaneously monthly for 4 months
PROJECTED ACCRUAL A total of 63 patients will be accrued for this study within 9 months
Primary
Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Beginning 6-12 weeks after curative hepatic resection patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1 15 29 and 45 then subcutaneously monthly for 4 months
PROJECTED ACCRUAL A total of 63 patients will be accrued for this study within 9 months
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-89903 | None | None | None |
| CDR0000069324 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |