A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or Progressive Intracranial Germ Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Response Rate
研究概览
简要总结
This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICGCT including pure germinoma and MMGCT.
- •Patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study.
- •Patients with mature/immature teratoma who have tumor marker elevations are eligible on this study.
- •Patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations.
排除标准
- •Patients with ICGCTs who are newly diagnosed are excluded from the study.
- •Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study.
- •Patients who are pregnant or breastfeeding are excluded from the study.
- •Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study.
- •Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study.
研究组 & 干预措施
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).
干预措施: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). (Drug)
结局指标
主要结局
Response Rate
时间窗: 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy
To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT
The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR)
时间窗: Mean follow-up of 44 months
次要结局
- OS and PFS(2 years, 3 years and 5 years)