Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed/Refractory Germ Cell Tumors

Recruiting now

Conditions studied: Prospective Observational Study, Gemcitabine, Docetaxel, Melphalan, Carboplatin, Stem Cell Transplantation, Pediatric Relapsed, Refractory Germ

In brief

To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.

Key facts

Study ID

NCT07662018

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2026-06-05

Expected to finish

2033-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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