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MUC1 Vaccine for Triple-negative Breast Cancer

Primary Purpose

Breast Cancer, Inflammatory Breast Cancer, Stage I Breast Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MUC-1 peptide vaccine
poly ICLC
MUC1 peptide-poly-ICLC adjuvant vaccine
laboratory biomarker analysis
enzyme-linked immunosorbent assay
flow cytometry
Sponsored by
Joseph Baar, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety and toxicity as assessed by NCI CTC

Full Information

First Posted
September 29, 2009
Last Updated
July 19, 2018
Sponsor
Joseph Baar, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT00986609
Brief Title
MUC1 Vaccine for Triple-negative Breast Cancer
Official Title
Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 19, 2009 (undefined)
Primary Completion Date
August 29, 2013 (Actual)
Study Completion Date
January 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Baar, MD, PhD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
MUC-1 peptide vaccine
Intervention Description
Given subcutaneously
Intervention Type
Biological
Intervention Name(s)
poly ICLC
Other Intervention Name(s)
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
Intervention Description
Given intramuscularly
Intervention Type
Biological
Intervention Name(s)
MUC1 peptide-poly-ICLC adjuvant vaccine
Intervention Description
Receive adjuvant vaccination
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
enzyme-linked immunosorbent assay
Other Intervention Name(s)
ELISA
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Proportion of patients showing a positive anti-MUC1 antibody response
Description
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.
Time Frame
At week 12 (2 weeks after the 3rd injection)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Baar, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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MUC1 Vaccine for Triple-negative Breast Cancer

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