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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

This study is currently recruiting participants.
Verified February 2017 by Jonathan Finlay, Nationwide Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270724
First Posted: January 5, 2011
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonathan Finlay, Nationwide Children's Hospital
  Purpose
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 Intervention Phase
CNS Germ Cell Tumor Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jonathan Finlay, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Response [ 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


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 4 months ]
    To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)


Estimated Enrollment: 28
Study Start Date: August 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: GemPOx

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270724


Contacts
Contact: Girish Dhall, MD 323-361-4629 gdhall@chla.usc.edu

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Girish Dhall, MD    323-361-8589    gdhall@chla.usc.edu   
Principal Investigator: Girish Dhall, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Girish Dhall, MD Children's Hospital Los Angeles
  More Information

Responsible Party: Jonathan Finlay, PI, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01270724     History of Changes
Other Study ID Numbers: GemPOx
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Gemcitabine
Oxaliplatin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs