Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Proportion of patients showing a positive anti-MUC1 antibody response
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: enzyme-linked immunosorbent assay (Other)
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
干预措施: MUC-1 peptide vaccine (Biological)
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
干预措施: MUC1 peptide-poly-ICLC adjuvant vaccine (Biological)
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
干预措施: laboratory biomarker analysis (Other)
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
干预措施: flow cytometry (Other)
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
干预措施: poly ICLC (Biological)
结局指标
主要结局
Proportion of patients showing a positive anti-MUC1 antibody response
时间窗: At week 12 (2 weeks after the 3rd injection)
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.
次要结局
- Safety and toxicity as assessed by NCI CTC(Weeks 0, 2, 4, 10, 12, 52, and 54 and then for 30 days after completion of study treatment)
研究者
Joseph Baar, MD, PhD
Principal Investigator
Case Comprehensive Cancer Center