Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Verified February 2012 by Children's Hospital Los Angeles
Information provided by (Responsible Party):
Girish Dhall, Children's Hospital Los Angeles
First received: January 4, 2011
Last updated: February 16, 2012
Last verified: February 2012
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.
CNS Germ Cell Tumor
Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270724
|Children's Hospital Los Angeles
|Los Angeles, California, United States, 90027 |
|Contact: Girish Dhall, MD 323-361-8589 firstname.lastname@example.org |
|Principal Investigator: Girish Dhall, MD |
Children's Hospital Los Angeles
||Girish Dhall, MD
||Children's Hospital Los Angeles
No publications provided
||Girish Dhall, PI, Children's Hospital Los Angeles
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2011
||February 16, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs