Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Phase 2

Completed

• Conditions: CNS Germ Cell Tumor
• Interventions: Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).

• Registration Number: NCT01270724
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Primary Completion: 2019-10-23
• Study Completion: 2019-12-09
• Results First Submitted: 2024-07-17
• Status Verified: 2025-10
• Results First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Results First Posted: 2025-10-27
• Last Update Posted: 2025-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)	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).

Primary Outcome Measures

Name	Time	Method
Response Rate	16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy	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
The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR)	Mean follow-up of 44 months

Secondary Outcome Measures

Name	Time	Method
OS and PFS	2 years, 3 years and 5 years	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).

Trial Locations

Locations (5)

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