Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
This study evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma.
详细描述
As prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new therapeutic modalities have to be developed to improve the patient´s clinical outcome. Immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is currently an intensively investigated, novel therapeutic option. As survivin is expressed both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this antigen is an intriguing target molecule. Spontaneous cytotoxic T-cell responses against different survivin epitopes in cancer patients underline the relevance of survivin-directed immunological trials. This study is comprised of a peptide vaccine with HLA-A1, -A2 and -B35 restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma, advanced pancreatic, colon and cervical carcinoma. The vaccine is applicated as a deep subcutaneous injection. Vaccination is administered for the first 2 months weekly, afterwards every 4 weeks. Standard staging examinations are performed every three months. Clinical, laboratory and immunological monitoring is done every month.Diagnostic leucapheresis is performed before first vaccination and afterwards every 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced melanoma, pancreatic, colon and cervical cancer
- •At least 1 prior postoperative conventional therapy (chemotherapy, radiation, immunotherapy)
- •HLA-A1, -A2, -B35
- •More than 4 weeks since last chemo-, immune- or radiotherapy
- •ECOG-PS (Eastern Cooperative Oncology Group- Performance Status) of 0-1
- •Sufficient renal, hepatic and bone marrow function: thrombocytes > 75.000/ul; hb > 9 g/dl; leucocytes > 2.500/ul; creatinine < 2 mg/dl; GOT/GPT < twice the normal value
- •negative for HIV and Hbs
- •Older than 18 years
- •Informed consent
排除标准
- •Acute/chronic infections
- •Positive for HIV, Hbs
- •Autoimmune disorders
- •Pregnancy, breast feeding
结局指标
主要结局
Progression-free survival
Overall survival
Immunological response
次要结局
- Best response
