About this trial
To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study
Trial population
MD Anderson Cancer Center
Trial design
Case-only
Prospective
Treatments tested in this trial
Gemcitabine (GEM)
DrugGive by Iv
Docetaxel
DrugGiven by Iv
Melphalan
DrugGiven by IV
Carboplatin
DrugGiven by Iv
Treatment groups
Trial outcomes
Primary outcomes
safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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