Observational Study of Treatment Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin with Autologous Stem Cell Transplantation in Children and Adolescents with Relapsed Germ Cell Tumors

What this Trial Is About

This research aims to understand treatment outcomes in children and adolescents with relapsed or refractory germ cell tumors who receive specific high-dose chemotherapy regimens and stem cell transplantation. The focus is on estimating overall survival and progression-free survival rates in patients undergoing tandem autologous stem cell transplants using gemcitabine, docetaxel, melphalan, and carboplatin GemDMC followed by a second transplant with carboplatin and etoposide CE. Participants undergo two consecutive high-dose chemotherapy courses with stem cell transplants. The first course includes gemcitabine, docetaxel, melphalan, and carboplatin administered intravenously over several days followed by stem cell infusion. The second course uses carboplatin and etoposide, also given intravenously, followed by a second stem cell infusion. This observational study follows patients receiving these treatments to collect data on their outcomes. During the study, researchers monitor safety and any adverse events for an average of one year after treatment completion. Information is collected on treatment responses and patient survival to better understand the effects of this approach. The study includes pediatric and adolescent patients treated with this regimen, including those who previously received it, to gather comprehensive outcome data over the course of participation.

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