drugset / Trial / NCT00607984

Administration of High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors

NCT00607984

Unknown 20 enrolled Rabin Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The prognosis of children and adolescents with high risk tumors of the central nervous system and other miscellaneous solid tumors is poor despite modern treatment protocols. Frequently, physicians suggest additional therapy with high dose chemotherapy after a good initial response to standard doses of treatment has been obtained, so as to reduce the chance that the tumor will recur. We propose a regimen of high dose thiotepa and melphalan followed by rescue of the patient's previously stored hematopoietic (blood manufacturing) system with blood stem cells. The aim of this study is to prove that this therapy is tolerable in children and adolescents, that it results in tolerable levels of toxicity, and that it improves the survival of this group of children as compared to standard therapy given in the past

Timeline

Start
2006-06
Primary completion
2010-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 140 mg/m2
Subject Thiotepa Other / unclassified 900 mg/m2