EUCTR2008-008211-26-IT进行中（未招募）不适用
Peptide-based vaccine in combination or not with chemotherapy in melanoma patients: a phase II randomized clinical study. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed AJCC stage IIIb or IIIc or IV (M1a or M1b) disease-free HLA- A*0201melanoma; Adult subjects of >18 years of age; ECOG score 0-1; Life expectancy of at least 6 months; Hematopoietic, liver and renal normal functions defined as follows: WBC > 3 x 103/μl; platelets > 100 x 103/μl; Hb >10 g/dl; absolute neutrophil count > 1,5 x 103/μl; bilirubin ≤ 2.0 mg/dl; AST, ALT and LDH less than 3 times upper limit of normal; serum creatinine ≤ 2 mg /dl; Fertile females have to practice adequate contraception; Signed informed consent;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated con-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; Concurrent chemotherapy or immunotherapy; Prior chemotherapy, immunotherapy or radiotherapy, unless ended at least 4, 4 and 4 weeks, respectively before admission to the present study; Significant cardiovascular diseases requiring medical intervention or prior myocardial infarction within the last 2 years; Primary or secondary immunodeficiency, including immunosuppressive disease, or use of immunosuppressive medications; Active or chronic infection (including HIV, HBV, HCV) Women must not be pregnant or breast-feeding; Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study; Any physical or psychological impediment in a patient that could let the investigator to suspect his/her poor compliance
研究者
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