Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 29, 2009
August 2, 2013
August 2009
December 2013   (final data collection date for primary outcome measure)
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.
Proportion of patients showing an immunologic response [ Time Frame: At week 16 following 4 injections ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00986609 on ClinicalTrials.gov Archive Site
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 ]
Safety and toxicity as assessed by NCI CTC [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
MUC1 Vaccine for Triple-negative Breast Cancer
Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer

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

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.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
  • 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
    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
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
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00986609
CASE16107, NCI-2009-01318
Yes
Joseph Baar, MD, Case Comprehensive Cancer Center
Joseph Baar, MD
Not Provided
Principal Investigator: Joseph Baar, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP