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MUC1 Vaccine for Triple-negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986609
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : July 23, 2018
Information provided by (Responsible Party):
Joseph Baar, MD, PhD, Case Comprehensive Cancer Center

Brief Summary:


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

Condition or disease Intervention/treatment Phase
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 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 Early Phase 1

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer
Study Start Date : August 19, 2009
Actual Primary Completion Date : August 29, 2013
Actual Study Completion Date : January 21, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 subcutaneously

Biological: poly ICLC
Given intramuscularly
Other Names:
  • Hiltonol
  • poly I:poly C with poly-1-lysine stabilizer
  • Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose
  • Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose
  • stabilized polyriboinosinic/polyribocytidylic acid

Biological: MUC1 peptide-poly-ICLC adjuvant vaccine
Receive adjuvant vaccination

Other: laboratory biomarker analysis
Correlative studies

Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA

Other: flow cytometry
Correlative studies

Primary Outcome Measures :
  1. Proportion of patients showing a positive anti-MUC1 antibody response [ Time Frame: At week 12 (2 weeks after the 3rd injection) ]
    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.

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986609

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United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Joseph Baar, MD, PhD
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Principal Investigator: Joseph Baar, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Responsible Party: Joseph Baar, MD, PhD, Principal Investigator, Case Comprehensive Cancer Center Identifier: NCT00986609    
Other Study ID Numbers: CASE16107
NCI-2009-01318 ( Other Identifier: NCI/CTRP )
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Poly I-C
Carboxymethylcellulose Sodium
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents