NCT00306553已完成2 期
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Able to provide written informed consent.
- •Able and willing to complete all protocol requirements.
- •Age: 18 years and older.
- •Histological confirmed stage III or IV melanoma.
- •At least one confirmed detectable target lesion
- •HLA-A*0201 haplotype
- •Expected survival of at least 6 months.
- •Full recovery from surgery.
- •Able to undergo either CT scan or MRI scan for tumor assessment.
- •Wash-out period of 4 weeks after chemotherapy
- •All AEs form prior anticancer therapy have resolved to ≤ Grade
- •Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
- •Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.
排除标准
- •Pregnant or nursing.
- •Use of an investigational drug within 30 days before enrolment.
- •Known or suspected brain metastases.
- •Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
- •Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders
- •Serum tests positive for HIV, HBV, HCV.
- •Active autoimmune diseases or severe allergies.
- •Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
- •Abuse of alcohol or other recreational drugs.
- •Previous vaccination with a Melan-A analog peptide.
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
1 期
Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical CancerMalignant MelanomaPancreatic CancerCervical CancerColon CancerNCT00108875Julius-Maximilians University70
已完成
1 期
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma PatientsMelanomaNCT00306514Cytos Biotechnology AG
终止
1 期
Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic CellsMelanomaNCT01783431Medical University of South Carolina1
终止
1 期
Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma PatientsMelanomaNCT01308294Centre Hospitalier Universitaire Vaudois16
已完成
1 期
Immunotherapy of Melanoma PatientsMelanomaNCT00112216Centre Hospitalier Universitaire Vaudois9