Clinical trial NCT00986609: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Proportion of patients showing a positive anti-MUC1 antibody response
timeFrame: At week 12 (2 weeks after the 3rd injection)
Secondary outcomes:
measure: Safety and toxicity as assessed by NCI CTC
timeFrame: Weeks 0, 2, 4, 10, 12, 52, and 54 and then for 30 days after completion of study treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Joseph Baar, MD
role: PRINCIPAL_INVESTIGATOR
References: