MUC1 Vaccine for Triple-negative Breast Cancer
This trial is active, not recruiting.
|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|
|Treatments||muc-1 peptide vaccine, poly iclc, muc1 peptide-poly-iclc adjuvant vaccine, laboratory biomarker analysis, enzyme-linked immunosorbent assay, flow cytometry|
|Sponsor||Joseph Baar, MD|
|Start date||August 2009|
|End date||August 2015|
|Trial size||29 participants|
|Trial identifier||NCT00986609, CASE16107, NCI-2009-01318|
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
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||single group assignment|
Proportion of patients showing a positive anti-MUC1 antibody response
time frame: At week 12 (2 weeks after the 3rd injection)
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
Female participants at least 18 years old.
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
|Official title||Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer|
|Principal investigator||Joseph Baar, MD|
|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.|
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