CompletedPhase 2

Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

United States10 participantsStarted 2010-08

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response Rate

Timeframe: 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)

Timeframe: Mean follow-up of 44 months

Trial details

NCT IDNCT01270724

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-23

Results submitted2024-07-17

View on ClinicalTrials.gov More CNS Germ Cell Tumor trials