Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2010-08-31
2019-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Interventions
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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Randal Olshefski, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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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
The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GemPOx
Identifier Type: -
Identifier Source: org_study_id
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