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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01270724
Collaborator
(none)
10
Enrollment
5
Locations
1
Arm
112.3
Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Oct 23, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Toxicity levels [4 months]

      To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Children's Hospital Phoenix Arizona United States 85016
    2 Children's Hospital Los Angeles Los Angeles California United States 90027
    3 New York University Langone Medical Center New York New York United States 10016
    4 Nationwide Children's Hospital Columbus Ohio United States 43205
    5 The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Nationwide Children's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01270724
    Other Study ID Numbers:
    • GemPOx
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal
    Gemcitabine
    Paclitaxel
    Oxaliplatin

    Study Results

    No Results Posted as of Jan 6, 2021