A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) Following Completion of Prescribed Chemotherapy or Trastuzumab for TXN2-3M0 or Metastatic Breast Cancer With No Evidence of Disease
The primary endpoint will be to determine the safety and feasibility of administering cancer
peptides to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence
of disease following their completion of systemic therapy, with the secondary objectives of
evaluating immune response disease relapse survival. Two cohorts of 9 patients each will be
treated with different doses of the vaccine. They will receive the peptide vaccine
subcutaneously on weeks 0,1,2,4,5, and 6 and then receive the immunizations every 1 month
for 6 months or disease recurrence. Toxicity will be assessed at each dose level using
CTCv3 toxicity criteria.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations.
Status post-3 immunizations
Michael Morse, M.D.
Duke University Cancer Center
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|