MUC1 Vaccine for Triple-negative Breast Cancer
NCT00986609 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2018-07-23
Summary
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 prevent or delay the recurrence of cancer.
PURPOSE:
To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic response to MUCI in patients with triple-negative BC
Conditions
- Breast Cancer
- 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
Interventions
- BIOLOGICAL
-
MUC-1 peptide vaccine
Given subcutaneously
- BIOLOGICAL
-
poly ICLC
Given intramuscularly
- BIOLOGICAL
-
MUC1 peptide-poly-ICLC adjuvant vaccine
Receive adjuvant vaccination
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
enzyme-linked immunosorbent assay
Correlative studies
- OTHER
-
flow cytometry
Correlative studies
Sponsors & Collaborators
-
Joseph Baar, MD, PhD
lead OTHER
Principal Investigators
-
Joseph Baar, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-19
- Primary Completion
- 2013-08-29
- Completion
- 2016-01-21
Countries
- United States
Study Locations
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