Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

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Brief Title

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 Toxicity levels

Condition

CNS Germ Cell Tumor

Intervention

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).

Study Arms / Comparison Groups

 Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Description:  Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

August 2010

Completion Date

December 9, 2019

Primary Completion Date

October 23, 2019

Eligibility 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Randal Olshefski, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01270724

Organization ID

GemPOx


Responsible Party

Sponsor

Study Sponsor

Nationwide Children's Hospital


Study Sponsor

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


Verification Date

January 2021