High risk/recurrent central nervous system (CNS) tumors have a poor prognosis so that tandem
high dose chemotherapy (HDCT) with hematopoietic progenitor stem cell rescues has been
chosen as potentially curative therapy. Many institutions have used carboplatin, thiotepa,
etoposide (CTE) for conditioning regimen of 1st HDCT and cyclophosphamide, melphalan (CM)
for conditioning regimen of 2nd HDCT. Our institution applied this regimen to the 38
pediatric patients with high risk brain tumor since 1996. Although the 3 year overall
survival rate and event free survival rate were improved to 69% and 47.9%, respectively, the
results showed relatively high treatment related mortality (TRM) rate of 21%. Toxicity of
this tandem regimen was also reported as being high up to 32% in other researches as well so
that this regimen is considered not feasible due to toxicity. In this study, the
investigators plan to improve event free survival rate and reduce treatment related
toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating
tandem high dose chemotherapy and autologous stem cell rescue with topotecan, thiotepa,
carboplatin (TTC) for 1st HDCT and melphalan, etoposide, carboplatin (MEC) for 2nd HDCT.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate event free survival rate
To evaluate event free survival rate after high dose chemotherapy and autologous stem cell rescue in pediatric patients with high risk brain tumor
1 month
No
Hyoung Jin Kang, M.D., Ph.D
Principal Investigator
Seoul National University Hospital
South Korea: Korea Food and Drug Administration (KFDA)
SNUCH-SCT-1102
NCT01342237
March 2011
February 2014
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