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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
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.
Details
| Lead sponsor | Nationwide Children's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2010-08 |
| Completion | 2019-12-09 |
Conditions
- CNS Germ Cell Tumor
Interventions
- Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Primary outcomes
- Response Rate — 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) — Mean follow-up of 44 months
Countries
United States