3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy 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
- 39
- 试验地点
- 1
- 主要终点
- Assess the Impact of High-dose 3F8/GM-CSF
研究概览
简要总结
The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.
Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.
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 (≥18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
- •The patients are in first CR/VGPR after conventional therapy. They have 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 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. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.
干预措施: 3F8 and 13-cis-retinoic acid (Drug)
结局指标
主要结局
Assess the Impact of High-dose 3F8/GM-CSF
时间窗: 2 years
on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.
次要结局
- Apply Real-time Quantitative RT-PCR(2 years)
- Monitor Safety of the High-dose Antibody Treatment(2 years)