Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
DrugTwo to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Other names: GemPOx
Completed
NCT Number: NCT01270724
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Phoenix Children's Hospital, Phoenix, Arizona, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Response Rate
Time frame: 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)
Time frame: Mean follow-up of 44 months
Secondary outcomes
-
OS and PFS
Time frame: 2 years, 3 years and 5 years
To assess the overall survival (OS) and event-free survival (EFS) of patients treated on the GemPOx induction regimen followed by the HDC and AuHPCR in patients with progressive or recurrent CNS GCT.
We hypothesize that specific CSF miRNA will prove to be accurate markers for tumor presence and predictors of response to therapy, with normalization being associated with improved progression-free survival (PFS) in patients under treatment for recurrent central nervous system (CNS) germ cell tumors (GCT).
Sponsors and collaborators
Lead sponsor
Nationwide Children's Hospital
Other
Registry information
Official study title
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
Important dates
- Study start
- 2010
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jan 5, 2011
- Registry last updated
- Oct 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.