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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

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ClinicalTrials.gov Identifier: NCT01270724
Recruitment Status : Recruiting
First Posted : January 5, 2011
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
CNS Germ Cell Tumor Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
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 : August 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: GemPOx




Primary Outcome Measures :
  1. 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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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
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Contact: Jonathan Finlay, MD 614-722-4087 Jonathan.Finlay@nationwidechildrens.org
Contact: Megan Jaeger, MPH 614-722-3686 Megan.Jaeger@nationwidechildrens.org

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Cynthia Wetmore, MD    602-933-0920    cwetmore@phoenixchildrens.com   
United States, California
Children's Hospital Los Angeles Active, not recruiting
Los Angeles, California, United States, 90027
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Sharon Gardner, MD    212-263-8400    Sharon.Gardner@nyulangone.org   
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jonathan Finlay, MD    614-722-4087    Jonathan.Finlay@nationwidechildrens.org   
The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Pierre Giglio, MD    614-293-4448    Pierre.Giglio@osumc.edu   
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Jonathan Finlay, MD Nationwide Children's Hospital

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Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01270724     History of Changes
Other Study ID Numbers: GemPOx
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Oxaliplatin
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