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

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

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

Primary Objectives To estimate the overall survival (OS) rate and progression free survival (PFS) associated with pediatric and adolescent participants with relapsed/refractory germ cell tumors who receive tandem transplantation with gemcitabine, docetaxel, melphalan, and carboplatin (GemDMC) followed by carboplatin and etoposide (CE) as a second tandem transplantation.

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