MUC1 Vaccine for Triple-negative Breast Cancer

NCT ID: NCT00986609

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-19
• Study Completion Date: 2016-01-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MUC-1 peptide vaccine

Intervention Type: BIOLOGICAL

Given subcutaneously

poly ICLC

Intervention Type: BIOLOGICAL

Given intramuscularly

MUC1 peptide-poly-ICLC adjuvant vaccine

Intervention Type: BIOLOGICAL

Receive adjuvant vaccination

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

enzyme-linked immunosorbent assay

Intervention Type: OTHER

Correlative studies

flow cytometry

Intervention Type: OTHER

Correlative studies

Interventions

MUC-1 peptide vaccine

Given subcutaneously

Intervention Type: BIOLOGICAL

poly ICLC

Given intramuscularly

Intervention Type: BIOLOGICAL

MUC1 peptide-poly-ICLC adjuvant vaccine

Receive adjuvant vaccination

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

enzyme-linked immunosorbent assay

Correlative studies

Intervention Type: OTHER

flow cytometry

Correlative studies

Intervention Type: OTHER

Other Intervention 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; ELISA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Joseph Baar, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Joseph Baar, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Baar, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

References

Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

Reference Type: DERIVED

PMID: 40443562 (View on PubMed)

Other Identifiers

NCI-2009-01318

Identifier Type: OTHER

Identifier Source: secondary_id

CASE16107

Identifier Type: -

Identifier Source: org_study_id