NCT01124240Unknown2 期
Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 12 month progression free survival
研究概览
简要总结
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.
Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).
After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed supratentorial GBM (WHO Grade IV,including GBM subtypes, e.g. gliosarcoma), histopathologically confirmed by central assessment as part of the screening for the CENTRIC trial.
- •Males or females ≥18 years of age.
- •Proven unmethylated MGMT gene promoter status, centrally assessed as part of the screening for the CENTRIC trial.
- •Written informed consent for the present trial obtained before undergoing any study-related activities. The informed consent also allows access to all information obtained during the screening for the CENTRIC trial, notably the result of the MGMT testing.
- •Available post-operative Gd-MRI performed within <48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization).
- •Stable or decreasing dose of steroids for >5 days prior to randomization.
- •ECOG PS of 0-
- •Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
- •Meets one of the following RPA classifications:
- •Class III (age <50 years and ECOG PS 0).
- •Class IV (meeting one of the following criteria:
- •Age <50 years and ECOG PS 1 or
- •Age ≥50 years, underwent prior partial or total tumor resection, Mini Mental State Examination [MMSE]≥27).
- •Class V (meeting one of the following criteria:
- •Age ≥50 years and underwent prior partial or total tumour resection, MMSE <27 or
- •Age ≥50 years and underwent prior tumor biopsy only).
- •Laboratory values (within 2 week prior to randomization):
- •Absolute neutrophil count ≥1500/mm
- •Platelets ≥ 100,000/mm
- •Creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance rate ≥60 mL/min
- •Prothrombin time (PT) international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits.
- •Hemoglobin ≥10 g/dL.
- •Total bilirubin ≤1.5 x the ULN.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN(except when attributable to anticonvulsants).
- •Alkaline phosphatase ≤ 2.5 x ULN.
- •Exclusion criteria
- •Subjects are not eligible for this study, if they fulfill one or more of the following exclusion criteria:
- •Prior chemotherapy within the last 5 years.
- •Prior RTX of the head.
- •Receiving concurrent investigational agents or has received an investigational agent(s) within the past 30 days prior to the first dose of Cilengitide .
- •Prior systemic antiangiogenic therapy.
- •Placement of Gliadel® wafer at surgery.
- •Treatment with a prohibited concomitant medication.
- •Planned surgery for other diseases (e.g. dental extraction).
- •History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
- •History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥ 5 years are eligible for this study.
- •History of coagulation disorder associated with bleeding or recurrent thrombotic events.
- •Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months. Uncontrolled arterial hypertension.
- •Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
- •Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at screening) or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
- •Current alcohol dependence or drug abuse.
- •Known hypersensitivity to the study treatment.
- •Legal incapacity or limited legal capacity.
- •Inability to undergo Gd-MRI.
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such.
排除标准
- 未提供
结局指标
主要结局
12 month progression free survival
时间窗: 3 years
次要结局
- Objective response(3 years)
- biomarker correlation with response(3 years)
- Toxicity(3 years)
- Peripheral WBC MGMT modulation(3 years)
研究者
研究点 (2)
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