NL-OMON50615已完成不适用
Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients with Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study (STEAM) - STEAM
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Specifics for groups A and B , - Newly diagnosed glioblastoma or anaplastic
- •astrocytoma, IDH1R132H-nonmutant by immunohistochemistry locally assessed, with
- •FFPE tissue available for central MGMT testing (treatment allocation will be
- •performed based on centrally assessed MGMT result)
- •- Tumor debulking surgery, including partial resection
- •- Age > 65 and considered non-eligible for combination therapy (TMZ/RT*TMZ) in
- •Investigator's opinion
- •- Brain MRI within 14 days before the first dose of TG02
- •- central assessment of MGMT promoter methylation , Specifics for group C , -
- •IDH1R132H-non-mutant glioblastoma or anaplastic astrocytoma at first relapse
- •with tissue available from first surgery
- •- Brain MRI at the time of progression or 14 days before the first dose of TG02
- •and availability of last brain MRI before progression diagnosis for upload to
- •the EORTC Imaging Platform for post-hoc central review of progression
- •- Diagnosis of recurrence more than 3 months after the end of RT for firstline
- •- Patient may have been operated for recurrence. If operated:
- •- surgery completed at least 2 weeks before initiation of TG02 and
- •patients should have fully recovered as assessed by investigator.
- •- a post-surgery MRI made within 72 hours; , - For non-operated
- •patients: recurrent disease must be at least one bidimensionally measurable
- •contrast-enhancing lesion with clearly defined margins by MRI scan, with
- •minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based
- •on a MRI scan done within 2 weeks prior to registration *
- •- Age * 18 years
- •- Intention to be treated with standard RT/TMZ*-- >TMZ for initial treatment
- •and at least one dose of TMZ administered; RT alone or chemotherapy alone as
- •initial treatment are not permitted, All groups
- •- Karnofsky Performance Score (KPS) of 60-100
- •- Recovered from effects of debulking surgery, postoperative infection and
- •other complications of surgery (if any) (CTCAE grade 0 and 1 acceptable)
- •- Adequate bone marrow, renal and hepatic function within the following ranges
- •within 7 days before the first dose of TG02:
- •* WBC * 3 x109/L
- •* ANC * 1.5x109/L
- •* Platelet count of * 100 x109/L independent of transfusion
- •* Hemoglobin * 10 g/dl or * 6.2 mmol/L
- •* Bilirubin * 1.5 × ULN
- •* ALT and AST * 2.5 × ULN
- •* Cockcroft*Gault calculated or measured creatinine clearance of * 30 mL/min
- •- Life expectancy > 8 weeks , - For men of reproductive potential and women of
- •childbearing potential: adequate contraception
- •- written informed consent
- •- Ability to take oral medication
排除标准
- •REGISTRATION , Specifics for groups A and B , * prior radiotherapy with overlap
- •of radiation fields with the planned radiotherapy in this study (Group A)
- •* prior therapy for glioblastoma or anaplastic astrocytoma before surgery ,
- •Specifics for group C , * discontinuation of TMZ for toxicity during first-line
- •* no other treatment except surgery for the treatment of the first recurrence ,
- •* use of enzyme-inducing anti-epileptic drugs (EI-AED) within 7 days prior to
- •the first dose of TG02 ,
- •* history of ventricular arrhythmia or symptomatic conduction abnormality in
- •past 12 months prior to registration
- •* congestive heart failure (New York Heart Association Class III to IV,
- •symptomatic ischemia, uncontrolled by conventional intervention, or myocardial
- •infarction within 6 months prior to enrollment
- •* prolonged QTc interval (males: > 450 ms; females: > 470 ms)
- •* known contraindication to imaging tracer or any product of contrast media
- •* MRI contraindications , * concurrent severe or uncontrolled medical disease
- •, * known human immunodeficiency virus infection or acquired immune deficiency
- •syndrome , * previous other malignancies, except for any previous malignancy
- •which was treated with curative intent more than 3 years prior to enrollment,
- •and except for adequately controlled limited basal cell carcinoma of the skin,
- •squamous carcinoma of the skin or carcinoma in situ of the cervix , * Negative
- •serum or urine pregnancy test within 72 hours prior to the first dose for
- •WOCBP. Nursing must be discontinued at least 1 hour before first dose.
- •* Known hypersensitivity to the active substance of any of the excipients in
- •the TG02 formulation, dacabarzine and temozolomide, * Any psychological,
- •familial, sociological or geographical condition potentially hampering
- •compliance with the study protocol and follow-up schedule
研究者
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