NCT01216826Unknown2 期
Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
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 the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma
研究概览
简要总结
The purpose of this study is to determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma.
The aim response is defined as complete or partial response (according to RECIST criteria) for at least 4 weeks, or stable disease for at least 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Osteosarcoma histological confirmation.
- •No option of known curative treatment, neither approved treatment that increases survival with adequate quality of life.
- •Karnofsky scale ≥ 50 for patients over 16 years and Lansky scale ≥ 50 for patients under 16 years.
- •Subjects should not have received antineoplastic therapy < 4 weeks before study treatment initiation.
- •Adequate hematological function: neutrophil count > 1.500/mm³, platelets > 100.000/mm³ and hemoglobin > 8.0 mg/dL.
- •Adequate renal function, as defined below:
- •Age Maximum serum creatinine (mg/dL) 0 - 29 days 0,4 - 0,7 1 month - 3 years 0,7 4 - 7 years 0,8 8 - 10 years 0,9 11 - 12 years 1,0 13 - 17 years 1,2
- •≥18 years 1,3
- •Adequate hepatic function: total bilirubin ≤ 1.5 x ULN and transaminases ≤ 2.5 x ULN.
- •Patient and/or legal responsible must sign ICF.
- •Life expectation > 8 weeks.
- •Measurable disease, according to RECIST criteria.
- •For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day
- •The patient agrees to 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
排除标准
- •History of myocardial infarction, angina or cerebrovascular accident related to atherosclerosis.
- •Pulmonary disorder (e.g. FEV1 or DLCO ≤ 70% upper expected).
- •Significant hematologic or hepatic abnormality (transaminases levels > 2.5 x ULN or serum bilirubin >1.5 x ULN, hemoglobin < 8 g/dL, platelets < 100.000/ mm3, ANC < 1.500/mm3).
- •Has other existing serious medical conditions that could adversely affect the ability of the patient to be treated in accordance with the 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.
- •If female, is pregnant or lactating.
- •Active infection at the moment of recruitment.
- •Previous history of organ transplantation.
- •Recent surgery < 2 months before entering study.
- •Concomitant antineoplastic therapy.
- •Patient received more than one rescue treatment, previously.
- •Previous treatment with mTor inhibitors (ex: sirolimus, temsirolimus, everolimus).
- •Use of investigational drug < 30 days before entering study.
- •Non-controlled hyperlipidaemia: serum cholesterol (fasting) > 300 mg/dL or 7,75 mmol/L and triglycerides (fasting) > 2,5 x ULN.
- •Non-controlled diabetes mellitus defined as: glycemia (fasting) > 1.5 x ULN.
- •Patient with hemorrhagic disorder or using oral anti-vitamin K (except warfarin in low doses).
- •Patient with HIV infection.
- •Incapable to perform protocol visits.
- •Another neoplasia for the last 2 years (except squamous or basocellular skin cancer).
- •Hypersensitivity history to rapamycin analogs.
- •Chronic treatment with corticoids (except per oral, topical or local treatment) or another immunosuppressor agent.
研究组 & 干预措施
Everolimus
Experimental
干预措施: Everolimus (Drug)
结局指标
主要结局
Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma
时间窗: Up to 2 years.
次要结局
- Define Everolimus toxicity in this population(Up to 2 years)
研究者
Sidnei Epelman
Director of Pediatric Oncology Department
Hospital Santa Marcelina
研究点 (1)
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