MUC1 Vaccine for Triple-negative Breast Cancer

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

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

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.

Inclusion Criteria:

• AJCC stage I-III infiltrating adenocarcinoma of the breast who have completed standard adjuvant or neoadjuvant therapy (surgery, radiation, biologic therapy, chemotherapy) for TNBC (ER-, PR-, HER-2/neu-)
• Patients who have completed standard therapy for triple-negative inflammatory BC are eligible
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Absolute neutrophil count >= 1,000/mm^3
• Hemoglobin >= 10.0 g/dl
• Platelet count >= 100,000/mm^3
• Total bilirubin must be within normal limits
• Transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is =< ULN
• Alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN
• Normal creatinine and blood urea nitrogen (BUN); if abnormal, calculated creatinine clearance must be >= 60 mg/dL
• Human immunodeficiency virus (HIV)(-), antinuclear antibody (ANA)(-), hepatitis panel (-), normal thyroid function tests; these tests will be performed at the discretion of the Investigator if warranted by history or clinical presentation
• Patients must be disease-free of prior invasive malignancies for >= 5 years, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• All patients must have completed surgery with sentinel and/or axillary lymph node dissection according to participating institutional guidelines
• All patients must have completed adjuvant radiation therapy according to participating institutional guidelines
• All patients must have completed either adjuvant or neoadjuvant chemotherapy according to participating institutional guidelines; the choice of chemotherapy is at the discretion of the treating physician
• Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using an accepted and effective barrier form method of contraception during participation in the study and for a reasonable period thereafter
• Patients must provide written informed consent

Exclusion Criteria:

• Known metastatic BC
• Radiotherapy, chemotherapy, biologic therapy, or other investigational therapy within the preceding 4 weeks
• Previous splenectomy or radiotherapy to spleen
• Coexisting or previous malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
• Active or uncontrolled infection
• Psychiatric, addictive, or any disorder that compromises the ability to give informed consent to participate in or to comply with the requirements of the study
• Concurrent systemic corticosteroid treatment - must be off all steroids for at least 4 weeks prior to vaccine administration
• Any condition or behavior that in the judgment of the Investigator, would compromise the patient's ability to participate in the study