Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304096
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2006-03-15
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 made from peptides may help the body build an effective immune response to kill tumor cells Giving booster vaccinations may make a stronger immune response and kill more tumor cells
PURPOSE This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer
PURPOSE This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast
Determine preliminarily the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine
Determine preliminarily the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells when available
OUTLINE This is an open-label study
Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1 8 15 36 57 and 78 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
Primary
Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast
Determine preliminarily the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine
Determine preliminarily the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells when available
OUTLINE This is an open-label study
Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1 8 15 36 57 and 78 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12 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-BREAST-34 | None | None | None |
| UVACC-HIT-0327 | None | None | None |
| UVACC-PRC-366-05 | None | None | None |
| UVACC-GCRC-DRB001 | None | None | None |