Overview

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Status:
Completed
Trial end date:
2019-12-09
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nationwide Children's Hospital
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Oxaliplatin
Paclitaxel
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.