NCT00424554已完成2 期
A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery
研究概览
简要总结
The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a brain tumor with high probability of being a glioma as detected by Magnetic Resonance Imaging (MRI). These would include newly diagnosed tumors or potentially recurrent gliomas.
- •No prior treatment for the tumor including chemotherapy or radiotherapy.
- •Amenable to surgery for biopsy or resection of the brain tumor. Surgically confirmed diagnosis of glioma (glioblastoma multiforme [GBM], anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA], astrocytoma [A] or oligodendroglioma [O]) will be
- •required for patients to be maintained in the study. Those not fulfilling this requirement will be discontinued and will be replaced.
- •Use of medically approved contraception in fertile males and females.
- •Women with childbearing potential must have a negative urine or serum
- •pregnancy test (urinary excretion or serum level of beta-Human Chorionic
- •Gonadotropin [bHCG]) within 72 hours of randomization.
- •Karnofsky Performance Status score >= 70%.
- •Signed informed consent form
排除标准
- •Prior chemotherapy.
- •Prior radiotherapy at the tumor site.
- •History of non-compliance to other therapies.
- •Inadequate haematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):
- •Absolute neutrophil count ≤1.5 x 10^9/L;
- •Platelets ≤100 x 10^9/L;
- •Haemoglobin <90 g/L;
- •Serum creatinine ≥1.5 times upper limit of laboratory normal;
- •Total serum bilirubin ≥1.5 times upper limit of laboratory normal (ULN);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ULN;
- •Alkaline phosphatase of > 2.5 ULN.
- •Known Human Immunodeficiency Virus [HIV] infection.
- •Known chronic hepatitis B or hepatitis C infection.
- •Any other serious medical condition according to the medical judgment of the physician prior to inclusion in the study.
- •Any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
研究组 & 干预措施
Temozolomide treatment
Experimental
干预措施: temozolomide (Drug)
结局指标
主要结局
MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery
时间窗: 14 days
An experimental assay was developed to measure MGMT levels.
次要结局
- MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels(14 days)
- Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities(12 months)
- Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)(12 months)
- Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor(14 days)
研究者
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