Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed/Refractory Germ Cell Tumors
M.D. Anderson Cancer Center
Summary
To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.
Description
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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:…
Interventions
- DrugGemcitabine (GEM)
Give by Iv
- DrugDocetaxel
Given by Iv
- DrugMelphalan
Given by IV
- DrugCarboplatin
Given by Iv
Location
- MD Anderson Cancer CenterHouston, Texas