MUC1 Vaccine for Triple-negative Breast Cancer

NCT00986609 | Completed Early Phase 1 DMC

• 2 other identifiers: CASE16107NCI-2009-01318
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients showing a positive anti-MUC1 antibody response

  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.

  At week 12 (2 weeks after the 3rd injection)

Secondary Outcomes (1)

• Safety and toxicity as assessed by NCI CTC

  Weeks 0, 2, 4, 10, 12, 52, and 54 and then for 30 days after completion of study treatment

Study Arms (1)

Arm I

EXPERIMENTAL

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; Biological: poly ICLC; Biological: MUC1 peptide-poly-ICLC adjuvant vaccine; Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: flow cytometry

Interventions

MUC-1 peptide vaccine BIOLOGICAL

Given subcutaneously

Arm I

poly ICLC BIOLOGICAL

Given intramuscularly

Also known as: 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

Arm I

MUC1 peptide-poly-ICLC adjuvant vaccine BIOLOGICAL

Receive adjuvant vaccination

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Arm I

flow cytometry OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Baar, MD, PhD: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 40443562 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

poly ICLC; Enzyme-Linked Immunosorbent Assay; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Joseph Baar, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: August 19, 2009
• Primary Completion: August 29, 2013
• Study Completion: January 21, 2016
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

US (1)