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
• 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
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

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	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

Secondary Outcome Measures

Name	Time	Method
Toxicity levels	4 months	To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)

Trial Locations

Locations (5)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, 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

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States