NCT00640861已完成1 期
MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria
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. It is not yet known which vaccine is most effective in treating breast cancer.
PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide vaccines combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as immune adjuvants suspended in Freund's incomplete adjuvant in patients with previously treated stage II or III adenocarcinoma of the breast.
Secondary
- To describe the impact of immunization on clinical outcomes in patients with MUC1-positive breast cancer in terms of disease-free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast
- •Clinical stage II or III disease
- •No radiographic evidence of disease at the time of enrollment
- •Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy
- •Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease
- •Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:
- •HER2 over-expression or amplification
- •Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)
- •MUC1-positive breast cancer
- •HLA-A2 positive
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 75,000/μL
- •ANC ≥ 1,500/uL
- •Creatinine ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 2 times ULN
- •No uncontrolled infection
- •No known HIV infection
- •No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Fully recovered from acute, reversible effects of any prior breast cancer therapy
- •No more than 3 years since prior surgery for primary breast cancer
- •Concurrent anti-estrogen therapy is allowed
- •No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
- •No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent
排除标准
- 未提供
结局指标
主要结局
Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria
Percentage of CD4+ T cells, CD8+ T cells, B cells, monocytes, and dendritic cells in a patient's peripheral blood sample as estimated by flow cytometry with a panel of monoclonal antibodies
Frequency of peptide-specific IFN-gamma producing T cells and peptide-specific IL-5 producing T cells estimated by ELISPOT after in vitro stimulation with peptide-sensitized stimulator cells for MUC1 and HER-2 peptides
次要结局
- Overall survival, defined as the time from registration to death due to any cause
- Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer
研究者
研究点 (3)
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