NCT00304096已完成1 期
Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Number of Participants Who Experienced Dose-limiting Adverse Events
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 kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.
- Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.
- Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).
OUTLINE: This is an open-label study.
Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Stage III or IV disease
- •Primary or recurrent disease
- •Invasive lobular carcinoma allowed
- •HLA-A1, -A2, -A3, or -A31 positive
- •Underwent and recovered from prior primary therapy
- •Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months
- •Must have at least one undissected axillary and/or inguinal lymph node basin
- •No history of brain metastases
- •Hormone receptor status
- •Estrogen receptor-positive or -negative tumor
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 0 or 1
- •Body weight > 110 lbs (without clothes)
- •Male or female
- •Menopausal status not specified
- •Absolute neutrophil count > 1000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •Hemoglobin A1c < 7%
- •AST and ALT ≤ 2.5 x upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 x ULN
- •Alkaline phosphatase ≤ 2.5 x ULN
- •Creatinine ≤ 1.5 x ULN
- •HIV negative
- •Hepatitis C negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known or suspected allergies to any component of the vaccine
- •No active infection requiring antibiotics
- •No New York Heart Association class III or IV heart disease
- •No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:
- •Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
- •Clinical evidence of vitiligo
- •Other forms of depigmenting illness
- •Mild arthritis requiring nonsteroidal antiinflammatory drugs
- •No medical contraindication or potential problem that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior surgery
- •More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy
- •More than 4 weeks since prior and no concurrent allergy desensitization injections
- •More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids
- •No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)
- •Prior or concurrent topical corticosteroids allowed
- •More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)
- •More than 4 weeks since prior and no concurrent other investigational medication
- •More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents
- •Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Stratum 1: Receiving Hormone Therapy
Experimental
Patients treated with 9 peptide vaccine who received hormone therapy
干预措施: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine (Biological)
Stratum 2: Not receiving hormone therapy
Experimental
Patients receiving 9 peptide vaccine who did not receive hormone therapy
干预措施: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine (Biological)
结局指标
主要结局
The Number of Participants Who Experienced Dose-limiting Adverse Events
时间窗: 30 days post administration of last vaccine
Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity
次要结局
- The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization(Days 1-78)
研究者
研究点 (1)
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