High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation in Patients With High-Risk Neuroblastoma: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival
研究概览
简要总结
The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.
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, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
- •The patients are post-stem cell transplantation and in first CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
- •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 v3.0) 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 monoclonal antibody and 13-cis-Retinoic Acid
This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.
干预措施: 3F8 monoclonal antibody and 13-cis-Retinoic Acid (Drug)
结局指标
主要结局
Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival
时间窗: 2 years
in patients who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of relapse.
次要结局
- Monitor Safety of the High-dose Antibody Treatment(2 years)
- Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow(2 years)