NCT01558453Unknown2 期
Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors
Sidnei Epelman1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
研究概览
简要总结
The purpose of this study is to determine the pediatric neoplastic response to chemotherapy proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
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
- •Age ≤ 21 years old at the time of cancer diagnosis.
- •Confirmed histological diagnosis - every patient, except brains tumor, or optic pathway glioma, should have one of the following histological diagnosis:
- •Ewing´s sarcoma/PNET
- •Osteosarcoma
- •Soft tissue sarcoma/rhabdomyosarcoma
- •Wilms tumor
- •Neuroblastoma
- •Retinoblastoma
- •Low grade astrocytoma
- •High grade astrocytoma/GBM
- •Ependymoma
- •Germ cell tumor Other rare tumors such as - hepatocellular carcinoma, pediatric colorectal carcinoma, renal cell carcinoma, adrenocortical carcinoma and nasopharyngeal carcinoma.
- •All subjects should have measurable disease, at least in one dimension, 20mm minimum, or presence of neoplastic cell in cephalorachidian fluid.
- •All patients must have a life expectancy ≥ 8 weeks, with PS Karnofsky ≥50 for patients with ≥ 10 years old and PS Lansky ≥50 for patients < 10 years old.
- •Previous treatment:
- •at least 3 weeks without chemotherapy.
- •at least 6 months after spine and brain radiation.
- •it is allowed corticosteroids in patients with CNS tumor, but it is recommended to have stable doses or reducing the dose 7 days before protocol treatment.
- •there´s no limit of drugs or chemotherapy used previously, except oxaliplatin.
- •Adequate function as define by:
- •Hematologic: neutrophil > 1000/mm³, platelet > 75000/mm³ and hemoglobin > 8 g/dL.
- •Renal - creatinine according to:
- •Age ≤ 5 anos Cr ≤ 0,8 mg/dL 5 < age < 10 Cr ≤ 1,0 mg/dL 10 < age ≤ 15 Cr ≤ 1,2 mg/dL > 15 years Cr ≤ 1,5 mg/dL
- •Hepatic: total bilirubin ≤ 3 mg/dL.
- •Neurologic: patients should seizure control.
- •Legal representative (father, mother or tutor) or subject (if >18 years old) must sign and date Informed Consent Form (ICF), after have being informed about relevant aspects regarding study participation.
- •For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day
- •Patient must agree in use effective contraception if procreative potential exists. Use of reliable means of contraception (e.g. hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier, abstinence) for subjects of reproductive potential (males and females) is required during study treatment and for 3 months following last dose of study drug
- •It should not have known curative treatment option and no proved therapy that increased survival with quality of life.
排除标准
- •Oxaliplatin previous use.
- •Another chemotherapy or experimental drug, simultaneously.
- •If female, pregnant or lactating.
- •Active infection.
- •Any serious existent condition that could affect, in adverse way, subjet's capacity to be treat according to protocol.
- •Any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.
- •Use of investigational drug < 30 days before entering study.
- •Medical history with:
- •severe renal insufficiency;
- •known hypersensitiveness to platine;
- •myelosuppression;
- •peripheral sensory neuropathy.
研究组 & 干预措施
Eloxatin
Experimental
Oxaliplatin
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.
时间窗: Up 2 years
次要结局
- Define cumulative toxicity after oxaliplatin multiple cycles in this population. Evaluate relation between time exposure to the drug (number of cycles) and response (antitumor effect x response).(Up 2 years)
研究者
Sidnei Epelman
Director of Pediatric Oncology Department
Hospital Santa Marcelina
研究点 (1)
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