MUC1 Vaccine for Triple-negative Breast Cancer - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00986609

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboxymethylcellulose Sodium

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Proportion of patients showing an immunologic 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:	August 2012 (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

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

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	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Joseph Baar 216-844-8683 joseph.baar@uhhospitals.org
Principal Investigator: Joseph Baar

Sponsors and Collaborators

Case Comprehensive Cancer Center

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:	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:	March 16, 2012
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
Adjuvants, Immunologic
Carboxymethylcellulose Sodium
Poly I-C
Poly ICLC

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Interferon Inducers

ClinicalTrials.gov processed this record on May 24, 2012