MUC1 Vaccine for Triple-negative Breast Cancer
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 prevent or delay the recurrence of cancer.
To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic response to MUCI in patients with triple-negative BC
Inflammatory Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-negative Breast Cancer
Biological: MUC-1 peptide vaccine
Biological: poly ICLC
Biological: MUC1 peptide-poly-ICLC adjuvant vaccine
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Other: flow cytometry
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer|
- Proportion of patients showing a positive anti-MUC1 antibody response [ Time Frame: At week 12 (2 weeks after the 3rd injection) ] [ Designated as safety issue: No ]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.
- Safety and toxicity as assessed by NCI CTC [ Time Frame: Weeks 0, 2, 4, 10, 12, 52, and 54 and then for 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive MUC-1 peptide vaccine subcutaneously and poly-ICLC vaccine intramuscularly in weeks 0, 4, 8, 12, 52, and 56, in the absence of disease progression or unacceptable toxicity. Patients may receive additional vaccines in weeks 34 and 38 if anti-MUC1 immunity falls below the two-fold enhancement from baseline
Biological: MUC-1 peptide vaccine
Given subcutaneouslyBiological: poly ICLC
Other Names:Biological: MUC1 peptide-poly-ICLC adjuvant vaccine
Receive adjuvant vaccinationOther: laboratory biomarker analysis
Correlative studiesOther: enzyme-linked immunosorbent assay
Other Name: ELISAOther: flow cytometry
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986609
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Joseph Baar, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|