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Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed/Refractory Germ Cell Tumors
RecruitingObservational study
Who can join
Ages 21 and older · All sexes
Full eligibility criteria
Inclusion Criteria * Male or female participants, greater than 1 month of age up to 21 years old. Neonates (birth to 1 month of age) will not be enrolled on this protocol. * Participants with relapsed/refractory seminomatous or nonseminomatous GCT who undergo an autologous stem cell transplantation (ASCT) with conditioning therapy including gemcitabine, docetaxel, melphalan, carboplatin (GemDMC) for germ cell tumors * As part of our analysis, we will also include participants aged 0-21 years old who have previously underwent ASCT with GemDMC * Participants who receive the following regimen: High dose chemotherapy (HDC) course #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin D-6 Admission and start hydration D-5 Gemcitabine 1,500 mg/m2 IV Docetaxel 275 mg/m2 IV D-4 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-3 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-2 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-1 Rest D0 Stem Cell infusion Followed by HDC course #2 consisting of: High-dose course #2: Carboplatin/Etoposide D-6 Admission and start hydration D-5 to -3 Etoposide 750 mg/m2 IV Carboplatin 700 mg/m2 IV D-2 Rest D-1 Rest D0 Stem Cell infusion Exclusion Criteria * Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study
About the study
To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.
What is being tested
- Gemcitabine (GEM) (drug)
- Docetaxel (drug)
- Melphalan (drug)
- Carboplatin (drug)
Sponsor: M.D. Anderson Cancer Center · Participants: 30 · Started: Jun 5, 2026
Contact the study team
- Irtiza N Sheikh, MD · Phone: (832) 728-9791
Official record on ClinicalTrials.gov — NCT07662018
Locations in the U.S.
| Texas | MD Anderson Cancer Center, Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.