Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
- 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
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
The Number of Participants Who Experienced Dose-limiting Adverse Events
Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity
30 days post administration of last vaccine
David R. Brenin, MD, FACS
University of Virginia
United States: Food and Drug Administration
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|