NCT01183897已完成2 期
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Assess the Activity of High-dose 3F8/GM-CSF
研究概览
简要总结
The purpose of this study is to see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
- •High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age) MYCN amplification or MYCN-amplified stage 4S.
- •Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined above) resistant to standard therapy, as evidenced by incomplete response in BM, but no measurable MIBG-avid soft tissue tumor assessable for response and no progressive disease.
- •Signed informed consent indicating awareness of the investigational nature of this program.
排除标准
- •Creatinine > 3.0 mg/dL
- •ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal
- •Bilirubin > 3.0 mg/dL
- •Patients with grade 3 or higher toxicities (using the CTCAE v 4.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
- •Progressive disease
- •History of allergy to mouse proteins.
- •Active life-threatening infection.
- •Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.
- •Inability to comply with protocol requirements.
研究组 & 干预措施
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Experimental
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
干预措施: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic (Biological)
结局指标
主要结局
Assess the Activity of High-dose 3F8/GM-CSF
时间窗: 2 years
against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.
次要结局
- Apply Real-time Quantitative RT-PCR(2 years)
- Monitor Safety of the High-dose Antibody Treatment(2 years)
研究者
研究点 (1)
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