Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

January 5, 2021 updated by: Nationwide Children's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Other Names:
  • GemPOx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 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
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Randal Olshefski, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 23, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GemPOx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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