Breast Cancer Clinical Trial
Official title:
Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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