Status:
COMPLETED
MUC1 Vaccine for Triple-negative Breast Cancer
Lead Sponsor:
Joseph Baar, MD, PhD
Conditions:
Breast Cancer
Inflammatory Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00986609
Start Date
August 19 2009
End Date
January 21 2016
Last Update
July 23 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106