Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Children's Hospital Los Angeles
Sponsor:
Information provided by (Responsible Party):
Girish Dhall, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01270724
First received: January 4, 2011
Last updated: February 16, 2012
Last verified: February 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Response [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
    Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Children's Hospital Los Angeles
Investigators
Principal Investigator: Girish Dhall, MD Children's Hospital Los Angeles
  More Information

No publications provided

Responsible Party: Girish Dhall, PI, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01270724     History of Changes
Other Study ID Numbers: GemPOx
Study First Received: January 4, 2011
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014