NCT01543464终止2 期
Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
Inge Marie Svane2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年5月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Clinical benefit rate (CBR)
研究概览
简要总结
The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.
详细描述
Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histological verified malignant melanoma
- •Metastatic disease (brain metastasis allowed if asymptomatic)
- •Evaluable disease recording to RECIST v. 1.1
- •Age > 18 years
- •Performance status, PS=0, PS=1 or PS=2
- •Life expectancy > 3 months
- •Adequate bone marrow function
- •Leucocyte count > 2,5 * 109/L
- •Granulocyte count > 1,5 * 109/L
- •Thrombocyte count > 100 * 109/l
- •Creatinine < 2,5 * UNL 130 micromol/L
- •Adequate liver function
- •ASAT < 100 U/L
- •Bilirubin < 300 U/L
- •S-hCG negative (fertile women)
- •Written informed consent
- •Inclusion at least 4 weeks after major abdominal surgery
- •If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion
排除标准
- •Treatment with immune suppressors (ie. prednisone) not allowed
- •Other malignancies 3 years prior to inclusion except benign skin lesions
- •Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
- •Acute/Chronic infection with HIV, hepatitis or tuberculosis
- •Known severe allergic reactions
- •Former anaphylactic reactions
- •Active autoimmune diseases
- •Pregnant or nourishing women
- •Psychiatric disease resulting in non-compliance
- •Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
- •Simultaneously treatment with other experimental drugs
- •Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.
结局指标
主要结局
Clinical benefit rate (CBR)
时间窗: 18 months
Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).
次要结局
未报告次要终点
研究者
Inge Marie Svane
MD, PhD & Professor
Herlev Hospital
研究点 (2)
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