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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
New York University Langone Medical Center
New York, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Response Rate
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
Time frame: 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy
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
OS and PFS
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).
Time frame: 2 years, 3 years and 5 years
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The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center
Columbus, Ohio, United States