Phase 2
Completed N=10
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
CNS Germ Cell Tumor
Source: ClinicalTrials.gov NCT01270724 ↗
Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Oct 2025
Primary outcomePrimary: Response Rate — 0; 0; 4; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
0; 0; 4; 2; 3; 0 | — |
| PRIMARY The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR) |
7 | — |
| SECONDARY OS and PFS |
66.7; 55.6; 44.4; 66.7; 66.7; 55.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01270724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.