MUC1 Vaccine for Triple-negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joseph Baar, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00986609
First received: September 29, 2009
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention 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
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of patients showing a positive anti-MUC1 antibody response [ Time Frame: At week 12 (2 weeks after the 3rd injection) ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: August 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986609

Locations
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
Investigators
Principal Investigator: Joseph Baar, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Joseph Baar, MD, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00986609     History of Changes
Other Study ID Numbers: CASE16107, NCI-2009-01318
Study First Received: September 29, 2009
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboxymethylcellulose Sodium
Poly I-C
Poly ICLC
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 10, 2014