Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343109
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2006-06-20
Brief Title:
Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase II Study of a HER-2Neu HER2 Intracellular Domain ICD Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-05
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:
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Detailed Description:
PRIMARY OBJECTIVES
1 To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine
SECONDARY OBJECTIVES
1 To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab
2 To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab
1 To determine the incidence of the development of T cell immunity specific for the HER2 ICD
2 To determine the incidence of the development of intramolecular epitope spreading
3 To determine the magnitude of the HER2 ICD specific CD4 and CD8 immune response generated with immunization
3 To assess whether there is an association between RFS and the development of an immune response HER2 specific T cell immunity andor the development of intramolecular epitope spreading
OUTLINE
Patients receive HER-2neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally ID once monthly for 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 4 8 and 12 months and then annually thereafter for up to 5 years
1 To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine
SECONDARY OBJECTIVES
1 To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab
2 To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab
1 To determine the incidence of the development of T cell immunity specific for the HER2 ICD
2 To determine the incidence of the development of intramolecular epitope spreading
3 To determine the magnitude of the HER2 ICD specific CD4 and CD8 immune response generated with immunization
3 To assess whether there is an association between RFS and the development of an immune response HER2 specific T cell immunity andor the development of intramolecular epitope spreading
OUTLINE
Patients receive HER-2neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally ID once monthly for 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 4 8 and 12 months and then annually thereafter for up to 5 years
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 |
|---|---|---|---|
| 120 | OTHER | Tumor Vaccine Group | None |
| NCI-2010-00803 | REGISTRY | None | None |
| BC 030289 | OTHER | None | None |