CNS Germ Cell TumorPhase 2NCT01270724

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

A Phase 2 study testing Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). in people with CNS Germ Cell Tumor, run by Nationwide Children's Hospital at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: CNS Germ Cell Tumor
What is being tested?: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 5 sitesUnited States
Study dates: Aug 2010to 9 Dec 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center
Columbus, Ohio, 43210
Children's Hospital Los Angeles
Los Angeles, California, 90027
New York University Langone Medical Center
New York, New York, 10016
Phoenix Children's Hospital
Phoenix, Arizona, 85016

Other trials in United States

About this study

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

Conditions: CNS Germ Cell Tumor
Being tested: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).Drug
Also called GemPOx
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.

Study groups in NCT01270724
Study group	Role	What they receive
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). Receives: Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: Mean follow-up of 44 months

Secondary outcomes (1)

OS and PFS
To assess the overall survival (OS) and event-free survival (EFS) of patients treated on the GemPOx induction regimen followed by the HDC and AuHPCR in patients with progressive or recurrent CNS GCT.
We hypothesize that specific CSF miRNA will prove to be accurate markers for tumor presence and predictors of response to therapy, with normalization being associated with improved progression-free survival (PFS) in patients under treatment for recurrent central nervous system (CNS) germ cell tumors (GCT).
Measured: 2 years, 3 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20109 Dec 2019

First posted5 Jan 2011 (estimated)
Study startAug 2010
Primary completion23 Oct 2019
Study completion9 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CNS Germ Cell TumorStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01270724
Sponsor's protocol ID: GemPOx
Status last verified: Oct 2025
First submitted: 4 Jan 2011
Last updated: 27 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All CNS Germ Cell Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01270724
Acronym / sponsor ID: GemPOx
Conditions: CNS Germ Cell Tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: Aug 2010
Primary completion: 23 Oct 2019 (actual)
Study completion: 9 Dec 2019 (actual)
First posted: 5 Jan 2011 (estimated)
Results: Posted 27 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)	Experimental	Drug: 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).Also: GemPOxTwo to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.	Drug	Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

Primary outcome

Response Rate
Time frame: 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy
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
The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR)
Time frame: Mean follow-up of 44 months

1 secondary outcome

OS and PFS
Time frame: 2 years, 3 years and 5 years

Results and safety

Results posted to the registry on 27 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)	10	7

Primary outcome: Response Rate

Time frame: 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy. Count of participants. Unit: Participants

Measure	Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) n = 9
CR, Complete Response	0
PR, Partial Response	0
SD, Stable Disease	4
PD, Progressive Disease	2
PR1, Partial Response with Normal Markers	3
PR2, Partial Response with Abnormal (but not rising) Markers	0

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

Time frame: Mean follow-up of 44 months. Count of participants. Unit: Participants

Measure	Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) n = 9
Value	7

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was followed for up to 5 months for adverse events (up to 4 cycles of Induction chemotherapy followed by one cycle of Consolidation therapy), or 30 days after the last dose of study drug was received. All-Cause Mortality was assessed for an average of 44 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)	2 of 10 (20%)	10 of 10 (100%)	4 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for CNS Germ Cell Tumor

RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
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RecruitingPhase 1
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Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Randal Olshefski, MD principal investigator

Nationwide Children's Hospital

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). in people with CNS Germ Cell Tumor, run by Nationwide Children's Hospital at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01270724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.