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首页> 美国卫生研究院文献>Neuro-Oncology >PT-04PRELIMINARY RESULTS OF A PHASE I/II STUDY OF INTRA-ARTERIAL CHEMOTHERAPY WITH OSMOTIC BLOOD-BRAIN BARRIER DISRUPTION FOR PATIENTS WITH RECURRENT OR PROGRESSIVE CNS EMBRYONAL OR GERM CELL TUMORS
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PT-04PRELIMINARY RESULTS OF A PHASE I/II STUDY OF INTRA-ARTERIAL CHEMOTHERAPY WITH OSMOTIC BLOOD-BRAIN BARRIER DISRUPTION FOR PATIENTS WITH RECURRENT OR PROGRESSIVE CNS EMBRYONAL OR GERM CELL TUMORS

机译：复发性或进展性中枢神经系统胚胎或生殖细胞肿瘤患者行渗透性血脑屏障损害的动脉化疗方案的I / II期研究的PT-04结果

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INTRODUCTION: Patients with refractory or recurrent CNS embryonal or germ cell tumors have poor prognosis and survivors suffer neuropsychological sequalae from radiotherapy and ototoxicity from chemotherapy. Prior retrospective studies suggest intra-arterial (IA) chemotherapy in conjunction with blood-brain barrier disruption (BBBD) may improve outcomes in patients with these challenging tumors. METHODS: In this prospective study, patients aged 1 to 30 with recurrent or refractory CNS embryonal or germ cell tumors were treated on 2 consecutive days, every 4 weeks, for up to a year with dose intensive IA carboplatin and IA melphalan with BBBD. The study objectives are to: determine the maximum tolerated dose of IA melphalan, estimate response rate, describe 2-year progression-free and overall survival, describe audiology and neuropsychological outcomes and describe overall toxicity. RESULTS: Nine patients were enrolled in the study (6 male) with a mean age was 14.75 years. There were three patients with medulloblastoma, two with atypical teratoid rhabdoid tumor, two with germ cell tumors, one with metastatic testicular teratoma, and one with PNET. The majority of patients thus far were treated at a melphalan dose of 6 mg/m2 for two days. Of the study participants two had stable disease, three had partial response, and three had disease progression. There were a total of 16 adverse events of grades three and higher with the majority being grade 3(63%). The most common adverse event was electrolyte disorder in 38% of patients, and bone marrow suppression in 25% of patients. CONCLUSIONS: This therapy is well tolerated and appears safe. The current melphalan dose is 6 mg/m2. Toxicity is predominantly related to electrolyte disturbances and bone marrow suppression. There appears to be a subgroup that responds to this therapy but further investigation is needed. The trial continues with further enrollment.
机译：引言：患有难治性或复发性中枢神经系统胚胎或生殖细胞肿瘤的患者预后较差，幸存者因放疗而遭受神经心理学困扰，而化疗则引起耳毒性。先前的回顾性研究表明，动脉内（IA）化疗结合血脑屏障破坏（BBBD）可能会改善这些具有挑战性肿瘤的患者的预后。方法：在这项前瞻性研究中，患有复发性或难治性中枢神经系统胚胎或生殖细胞肿瘤的1至30岁患者每2周连续2天接受剂量密集的IA卡铂和IA melphalan联合BBBD治疗，长达一年。研究目的是：确定IA melphalan的最大耐受剂量，估计缓解率，描述2年无进展生存期和总体生存率，描述听力学和神经心理学结果并描述总体毒性。结果：该研究共纳入9例患者（6例男性），平均年龄为14.75岁。髓母细胞瘤3例，非典型性畸胎瘤样横纹肌瘤2例，生殖细胞瘤2例，睾丸转移性畸胎瘤1例，PNET 1例。迄今为止，大多数患者均以6 mg / m2的美法仑剂量治疗了两天。在研究参与者中，两名患有疾病，三名患有部分反应，三名患有疾病进展。共有16个三级及以上的不良事件，大多数为3级（63％）。最常见的不良事件是38％的患者出现电解质紊乱，而25％的患者出现了骨髓抑制。结论：该疗法耐受性好，似乎安全。当前的美法仑剂量为6 mg / m2。毒性主要与电解质紊乱和骨髓抑制有关。似乎有一个亚组对此疗法有反应，但需要进一步研究。该试验将继续进行，并进行进一步的注册。

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