Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CNS Germ Cell Tumor

Intervention / Treatment
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* Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)<br>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).<br>* Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.<br>* Other names: GemPOx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity levels | To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT) | 4 months |