EUCTR2014-002446-47-DE进行中（未招募）1 期
Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
European Organization for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 86 人开始时间: 2015年8月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •?Age 18 or older.
- •?Histological diagnosis of WHO grade II (chordoid meningioma, clear
- •cell meningioma, atypical meningioma) or WHO grade III (papillary
- •meningioma, rhabdoid meningioma, anaplastic/malignant meningioma) according to WHO 2007 classification.
- •?Radiologically documented progression of any existing tumor (growth > 25% in the last year) or appearance of new lesions (including intraand extracranial manifestations).
- •?Measurable disease (10 x10 mm) on cranial MRI or CT
- •thorax/abdomen no more than 2 weeks prior to randomization
- •?WHO performance status 0-2
- •?Adequate liver, renal and hematological function within 2 weeks prior to randomization, defined as:
- •?Neutrophils = 1.5 x 109/L, hemoglobin = 9 g/dL or hemoglobin =
- •5.6 mmol/L, platelets = 100 x 109/L
- •?Total Bilirubin = ULN, SGPT/ALT and SGOT/AST = 2.5 x ULN
- •?Alkaline phosphatase = 2.5 x ULN; if alkaline phosphatase > 2.5 ULN,
- •hepatic isoenzymes 5-nucleotidase or gamma glutyamyltransferase
- •(GGT) must be within the normal range
- •?Albumin = 30 g/L
- •?Serum creatinine = 1.5 x ULN
- •?Creatinine clearance > 30 ml/min as calculated by Cockcroft and
- •Gault formula (see Appendix E)
- •?Creatine phosphokinase (CPK) = 2.5 x ULN
- •?Normal cardiac function (LVEF assessed by MUGA or ECHO within
- •normal range of the institution), normal 12 lead ECG (without clinically
- •significant abnormalities). The following unstable cardiac conditions are not allowed:
- •?Congestive heart failure
- •?Angina pectoris
- •?Myocardial infarction within 1 year before registration/randomization
- •?Uncontrolled arterial hypertension defined as blood pressure =
- •150/100 mm Hg despite optimal medical therapy
- •?Arrhythmias clinically significant
- •?Life expectancy of at least 9 weeks
- •Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior randomization (and again within 72 hours prior to the first dose of study treatment). Patients of childbearing / reproductive potential should use adequate birth control measures, as defined below, during the study treatment period and for at least 3 months after the last study treatment. Men who are fertile must use effective contraception during treatment with trabectedin and for 5 months thereafter. Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
- •? combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation:
- •? intravaginal
- •? transdermal
- •? progestogen-only hormonal contraception associated with inhibition
- •of ovulation:
- •? injectable
- •? implantable
- •? intrauterine device (IUD)
- •? intrauterine hormone-releasing system ( IUS)
排除标准
- •?More option for local therapy (resection or radiotherapy) after maximal feasible surgery and radiotherapy.
- •?Prior systemic anti-neoplastic therapy for meningioma (patient may have received prior radionuclide therapy).
- •?History of any other invasive malignancy within the last 5 years
- •(except adequately treated non-melanoma skin cancer, clinicaly
- •localized and very low risk prostate cancer, and adequately treated
- •cervical intraepithelial neoplasia).
- •?Serious illness or medical conditions, specifically: active infectious
- •process; chronic active liver disease, including chronic hepatitis B, C or
- •? Concomitant use of any other investigational agent, phenytoin, or
- •vaccination to yellow fever.
- •? Known hypersensitivity or contraindication to trabectedin or any of
- •the ingredients of the trabectedin solution for infusion
- •? Known MRI or CT, including contrast media, contraindications.
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