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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Primary Purpose

CNS Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CNS Germ Cell Tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital
  • Children's Hospital Los Angeles
  • New York University Langone Medical Center
  • Nationwide Children's Hospital
  • The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Arm Description

Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 4, 2011
Last Updated
January 5, 2021
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01270724
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CNS Germ Cell Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Arm Type
Experimental
Arm Description
Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Other Intervention Name(s)
GemPOx
Intervention Description
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Primary Outcome Measure Information:
Title
Response rate
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Toxicity levels
Description
To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal Olshefski, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

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