MUC1 Vaccine for Triple-negative Breast Cancer
This study is currently recruiting participants.
Verified September 2012 by Case Comprehensive Cancer Center
Sponsor:
Case Comprehensive Cancer Center
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00986609
First received: September 29, 2009
Last updated: September 18, 2012
Last verified: September 2012
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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 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:
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: | September 18, 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 23, 2013