Phase II single arm institutional study to assess Dinutuximab combined with the cytokines granulocyte-macrophage colony stimulating factor (GM-CSF) and IL-2 in patients with high-risk neuroblastoma not eligible to other immunotherapy trials

Fundació Sant Joan de Deu de Barcelona0 个研究点开始时间: 2014年4月1日最近更新: 2014年6月2日

适应症

试验速览

暂无简介。

•1. Diagnosis of neuroblastoma as defined by international criteria by histopathology or bone marrow metastases.
•2. Neuroblastoma, as defined by risk-related treatment guidelines and the International Neuroblastoma Staging System, stage 4 with (any age) or without (>18 months) MYCN-amplification, or MYCN-amplified neuroblastoma other than stage 1, or high-risk neuroblastoma defined based on the 3-gene molecular profile.
•Group 1 patients have neuroblastoma (as defined above) resistant to standard therapy, as evidenced by incomplete response in bone marrow, but no MIBG-avid soft tissue or bone tumor and no progressive disease.
•Group 2 patients have no evidence of measurable disease, i.e., are in CR/VGPR from neuroblastoma (as defined above).
•3. Signed informed consent indicating awareness of the investigational nature of this program.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Existing severe major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity >/= grade 3.
•2. Progressive disease or MIBG-avid soft tissue/bone tumor.
•3. Active life-threatening infection.
•4. Inability to comply with protocol requirements.
•5. Patient is elegible for SIOP HR-NB-01 protocol.

发起方

Fundació Sant Joan de Deu de Barcelona