Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

NCT01270724 | Completed Phase 2 Results DMC

• 1 other identifier: GemPOx
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

CNS Germ Cell Tumor

Outcome Measures

Primary Outcomes (2)

• 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

  16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy

• The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR)

  Mean follow-up of 44 months

Secondary Outcomes (1)

• OS and PFS

  2 years, 3 years and 5 years

Study Arms (1)

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

EXPERIMENTAL

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).

Interventions

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). DRUG

Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.

Also known as: GemPOx

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (5)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Gemcitabine; Paclitaxel; Oxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Megan Blue
• Organization: Nationwide Children's Hospital

megan.blue@nationwidechildrens.org

614-722-3686

Study Officials

• Randal Olshefski, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: August 1, 2010
• Primary Completion: October 23, 2019
• Study Completion: December 9, 2019
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Locations

US (5)