胶质瘤—放射与免疫临床试验.pptxVIP

Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected手术week1局部放疗Week2-8未复发病人，皮内注射经放疗的自体肿瘤细胞+GM-CSF week10-12再注射自体疫苗week16每两周接种1次，持续3次（optional） For the first three weeks of this study, vaccines will be given once each week. After the first three weeks, vaccines will be given every other week. Before the first and after the fourth vaccinations, a small amount of the participants own irradiated tumor cells will be injected under their skin to see if their immune system will react against it. If the participant develops a rash, they may be asked to undergo a small skin biopsy for additional evaluation. These biopsies are optional.疫苗：经致死剂量的自体肿瘤细胞和经放射的GM-K562细胞（具有分泌GM-CSF功能）手术week1皮内注射疫苗week2-4，每周一次皮内注射疫苗两周一次第一次接种前或共接受疫苗4次后，皮肤注射自体经放射的肿瘤细胞皮肤出现皮疹时，活检 The purpose of phase I trial is to determine the safest, most effective dose of MK-3475 (pembrolizumab), when used with?radiotherapy?and temozolomide for treating newly diagnosed patients with glioblastoma (GBM). Phase II trial will evaluate if MK-3475 used in combination with temozolomide and?radiation?followed by?radiationand temozolomide to see if this is better than using?radiation?and temozolomide alone. Temozolomide binds to the deoxyribonucleic acid (DNA), changes it, and triggers the death of tumor cells. MK-3475 is an investigational drug, it is not currently approved by the Federal Drug Administration (FDA) for use in treating GBM but it is approved for treating melanoma. MK-3475 works by targets the local tumor?immune-protection in solid tumors. It is hoped the addition of MK-3475 to the usual treatment for GBM will improve the cu