MUC1 Vaccine for Triple-negative Breast Cancer
Completed · Early Phase 1
Conditions studied: 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
In brief
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
Key facts
- Study ID
- NCT00986609
- Run by
- Joseph Baar, MD, PhD
- People needed
- 29
- Starts
- 2009-08-19
- Expected to finish
- 2016-01-21
- Last updated by the study team
- 2018-07-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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