Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT
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
- 否
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
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
Dong-Sup Chung
Professor, Department of Neurosurgery
Incheon St.Mary's Hospital
