NCT01254838已完成1 期
Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments
- •PATIENTS CHARACTERISTICS
- •Patients who showed resistance to hormonal therapy and chemotherapy
- •Histological diagnosis is adenocarcinoma
- •HLA-A*0201/0206
- •ECOG performance status of 0 to 2
- •Age ≥ 20 years, ≤80 years
- •WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg
- •life expectancy ≥ 3months
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- •Serious infections requiring antibiotics
- •Concomitant treatment with steroids or immunosuppressing agent
- •Other malignancy difficult to control.
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 2 years
hematological and non-hematological adverse event
次要结局
- CTL reaction(2 years)
研究者
相似试验
终止
1 期
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of MelanomaMelanomaNCT02425306Craig L Slingluff, Jr48
Unknown
1 期
Novel Peptide Vaccination for Patients With Advanced Prostate CancerProstate CancerNCT01225471Iwate Medical University30
已完成
1 期
Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung CancerNon Small Cell Lung CancerNCT00874588Fukushima Medical University6
已完成
1 期
A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma PatientsMelanomaNCT01585350Craig L Slingluff, Jr53
招募中
1 期
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative NeoplasmEssential ThrombocythemiaMyelofibrosisMPNNCT05025488Marina Kremyanskaya10