Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
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|ClinicalTrials.gov Identifier: NCT01270724|
Recruitment Status : Recruiting
First Posted : January 5, 2011
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|CNS Germ Cell Tumor||Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).
Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Other Name: GemPOx
- Response [ Time Frame: 4 months ]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
- Toxicity [ Time Frame: 4 months ]To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270724
|Contact: Girish Dhall, MDfirstname.lastname@example.org|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Girish Dhall, MD 323-361-8589 email@example.com|
|Principal Investigator: Girish Dhall, MD|
|Principal Investigator:||Girish Dhall, MD||Children's Hospital Los Angeles|