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临床试验/NCT01847235
NCT01847235已完成2 期

The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年5月最近更新:
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
23
试验地点
1
主要终点
Progression free survival (PFS)

研究概览

简要总结

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

详细描述

Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion.

During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven anaplastic oligodendroglioma or oligoastrocytoma
  • Progressed or relapsed after surgery or radiation therapy
  • Female or male aged 20 years or over
  • At least 1 measurable mass lesion
  • ECOG performance status 0-3
  • Adequate organ function
  • absolute neutrophil count > 1,500/μL
  • platelet count > 75,000/μL
  • hemoglobin greater than 9 g/dL or 900g/L
  • serum creatinine less than 1.5 times the upper limit of laboratory normal
  • total serum bilirubin less than 1.5 times the upper limit of laboratory normal
  • AST or ALT less than three times the upper limit of laboratory normal

排除标准

  • Prior course of temozolomide
  • Combined glioblastoma
  • Pregnant woman

研究组 & 干预措施

Temozolomide

Experimental

Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days

干预措施: Temozolomide (Drug)

结局指标

主要结局

Progression free survival (PFS)

时间窗: 6 month

PFS will be examined with Kaplan-Meier method.

次要结局

  • Overall survival (OS)(1 years)
  • progression-free survival (PFS)(1 year)
  • Objective response rate (ORR)(1 year)
  • Number of Participants with Adverse Events(1 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Min Kim

Associate Professor

Seoul National University Hospital

研究点 (1)

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