Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091286
Status:
TERMINATED
Last Update Posted:
2020-03-30
First Post:
2004-09-07
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIB Stage III or Stage IV Colorectal Cancer
Sponsor:
Craig L Slingluff Jr
Organization:
University of Virginia
Study Overview
Official Title:
Evaluation of the Immunogenicity of Vaccination With HER-2Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant in Patients With Stage IIB III or IV Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accruals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from peptides may make the body build an immune response to kill tumor cells
PURPOSE This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB stage III or stage IV colorectal cancer
PURPOSE This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB stage III or stage IV colorectal cancer
Detailed Description:
OBJECTIVES
Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides sargramostim GM-CSF and Montanide ISA-51 causes an immune response in patients with stage IIB III or IV colorectal cancer
Determine the safety of this regimen in these patients
OUTLINE Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides sargramostim GM-CSF and Montanide ISA-51 on days 1 8 and 15 On day 22 patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine
PROJECTED ACCRUAL A maximum of 15 patients will be accrued for this study
Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides sargramostim GM-CSF and Montanide ISA-51 causes an immune response in patients with stage IIB III or IV colorectal cancer
Determine the safety of this regimen in these patients
OUTLINE Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides sargramostim GM-CSF and Montanide ISA-51 on days 1 8 and 15 On day 22 patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine
PROJECTED ACCRUAL A maximum of 15 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 |
|---|---|---|---|
| UVACC-23302 | None | None | None |
| UVACC-GI37 | None | None | None |