A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
OBJECTIVES:
I. Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.
II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.
V. Correlate the extent of oxaliplatin exposure with response in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed* solid tumor, including any of the following:
- •Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- •Osteosarcoma
- •Rhabdomyosarcoma
- •Neuroblastoma
- •High-grade astrocytoma
- •Low-grade astrocytoma
- •Glioblastoma multiforme
- •Ependymoma
- •Hepatoblastoma
- •Germ cell tumors of any site
- •Rare tumors of interest, including any of the following:
- •Soft tissue sarcoma
- •Hepatocellular carcinoma
- •Childhood/adolescent colorectal carcinoma
- •Childhood/adolescent renal cell carcinoma
- •Childhood/adolescent adrenocortical carcinoma
- •Childhood/adolescent nasopharyngeal carcinoma
- •Recurrent disease OR refractory to conventional therapy
- •Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography
- •Performance status - Karnofsky 50-100% (for patients over age 10)
- •Performance status - Lansky 50-100% (for patients age 10 and under)
- •At least 8 weeks
- •Absolute neutrophil count ≥ 1,000/mm^3*
- •Platelet count ≥ 75,000/mm^3* (transfusion independent)
- •Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed)
- •Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met
- •Bilirubin ≤ 3 mg/dL
- •Creatinine based on age as follows:
- •≤ .8 mg/dL (for patients age 5 and under)
- •≤ 1.0 mg/dL (for patients age 6 to 10)
- •≤ 1.2 mg/dL (for patients age 11 to 15)
- •≤1.5 mg/dL (for patients age 16 to 21)
- •Creatinine clearance or radioisotope glomerular filtration rate > 20 mL/min
- •No uncontrolled seizure disorder
- •No uncontrolled infection
- •CNS toxicity ≤ grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Recovered from prior immunotherapy
- •At least 7 days since prior anticancer biologic therapy
- •More than 1 week since prior growth factors
- •At least 6 months since prior allogeneic stem cell transplantation
- •No evidence of active graft-vs-host disease
- •No concurrent immunomodulating agents
- •Recovered from prior chemotherapy
- •No prior oxaliplatin
- •Prior carboplatin or cisplatin allowed
- •More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Response rate
时间窗: Up to 3 years
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.
次要结局
未报告次要终点