跳至主要内容
临床试验/NCT01737346
NCT01737346Unknown2 期

Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT

Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
52
试验地点
1
主要终点
6-month progression free survival

研究概览

简要总结

The combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. However, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is no efficient and standard care at the time of recurrence or progression following temozolomide administration. Recently, many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrent/refractory glioblastoma. It is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings. We have realized that the clinical features of Korean patients are very different from those of foreign patients. Therefore, it is mandatory to develop the new strategy for the treatment of Korean patients. We modify the PCV chemotherapy in the dose and administration schedule of CCNU and procarbazine to reduce the side effect, especially hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the first multicenter trial for glioblastoma patients in Korea.

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 or radiologically confirmed progressive or recurrent glioblastoma with methylated MGMT promoter
  • Within 6 months after or during Stupp regimen (TMZ-RT CCRT + adjuvant TMZ), or After re-treatment of cyclic TMZ, 6 months later after Stupp regimen
  • KPS ≥ 60%
  • Age ≥ 20 years
  • At least two weeks apart from prior surgery and prior chemotherapy
  • Adequate hematologic, liver, and renal functions
  • Unstained slides for central pathology review
  • Signed informed consent

排除标准

  • Prior malignancy within 5 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix
  • maternity or breastfeeding
  • Evidence of active infection within 2 weeks prior to study
  • Previous treatment with procarbazine and/or CCNU
  • Evidence of leptomeningeal metastasis
  • Unable to comply with the study protocol

研究组 & 干预措施

lomustine and procarbazine

Experimental

1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles

干预措施: lomustine and procarbazine (Drug)

结局指标

主要结局

6-month progression free survival

时间窗: March 31, 2014

次要结局

未报告次要终点

研究者

发起方
Incheon St.Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Sup Chung

Professor, Department of Neurosurgery

Incheon St.Mary's Hospital

研究点 (1)

Loading locations...

相似试验