Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer
I. To evaluate the efficacy of MUC1 peptide-poly-ICLC adjuvant vaccine in boosting systemic
immunity to MUC1 in women who have completed therapy for AJCC(American Joint Committee on
Cancer)stage I-III 'triple-negative' [i.e., ER(-) PR(-) HER2/neu(-)] breast cancer.
I. To evaluate the safety and toxicity of the MUC1 peptide and poly-ICLC vaccine in this
cohort of patients.
Patients receive MUC-1 peptide vaccine subcutaneously (SC) and poly-ICLC vaccine SC in weeks
0, 2, and 10 in the absence of disease progression or unacceptable toxicity. Some patients
may receive a booster vaccine in week 52. Patients will be followed for study-related
Serious Adverse Events (SAEs) for a period of 30 days after their last vaccination. If a
patient experiences a SAE while participating in this study, they will be followed until the
resolution of the SAE.
Intervention Model: Single Group Assignment, Masking: Open Label
Proportion of patients showing a positive anti-MUC1 antibody response
Defined as a >= 2-fold enhancement from baseline anti-MUC1 antibody immunity, or for subjects with no antibody to MUC1 at baseline, any detectable antibody immunity against MUC1. To test the hypothesis of a sufficient immunologic response, we will apply a Simon's optimum 2-stage design. The proportion of patients with an immunologic response will be calculated with a 95% confidence interval using method developed for multistage clinical trials.
At week 12 (2 weeks after the 3rd injection)
Joseph Baar, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|