Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194714
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2005-09-13
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase III Study of Combination Immunotherapy for the Generation of HER-2Neu HER2 Specific Cytotoxic T Cells CTL in Vivo
Status:
COMPLETED
Status Verified Date:
2024-05
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 III trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex class I A2 antigen HLA-A2 and human epidermal growth factor receptor 2 HER2 positive breast or ovarian cancer who are receiving trastuzumab Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety of administering a HER2 cytotoxic T-cell CTL peptide-based vaccine HER-2neu peptide vaccine to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab
II To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell PBMC of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab
SECONDARY OBJECTIVES
I To evaluate overall survival OS in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab
OUTLINE
Patients receive HER-2neu peptide vaccine intradermally ID once per month for 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 3 6 and 12 months and then yearly for up to 5 years
I To evaluate the safety of administering a HER2 cytotoxic T-cell CTL peptide-based vaccine HER-2neu peptide vaccine to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab
II To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell PBMC of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab
SECONDARY OBJECTIVES
I To evaluate overall survival OS in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab
OUTLINE
Patients receive HER-2neu peptide vaccine intradermally ID once per month for 6 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 3 6 and 12 months and then yearly 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 |
|---|---|---|---|
| NCI-2016-00895 | REGISTRY | None | None |
| 6304 | OTHER | None | None |
| P30CA015704 | NIH | None | None |
| RG1000607 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |