NCT00986609

MUC1 Vaccine for Triple-negative Breast Cancer

Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Joseph Baar, MD, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity of the MUC1 peptide and poly-ICLC vaccine in this cohort of patients. OUTLINE: 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.

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

Type	Name	Description
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

Timeline

• Start date: 2009-08-19
• Primary completion: 2013-08-29
• Completion: 2016-01-21
• First posted: 2009-09-30
• Last updated: 2018-07-23

Locations

1 site across 1 country: United States