Brain Tumor Clinical Trial
Official title:
Irinotecan, Vincristine, Etoposide, Carboplatin, and Cyclophosphamide for Refractory or Relapsed Brain Tumor in Children and Adolescents
The outcome of pediatric refractory or relapsed brain tumor is very dismal. Standard
chemotherapy showed poor response to these patients. Although tandem high dose chemotherapy
with hematopoietic progenitor stem cell rescues has been chosen as a potentially curative
therapy for long term survival and better outcome is expected if tumor burden before
transplantation reduced by chemotherapy, effective salvage chemotherapy for tumor reduction
is not established yet. Irinotecan is a recently developed topoisomerase I inhibitor, and
there are preclinical and phase I, II data which proved practical effects in brain tumors.
In those studies, irinotecan was administered alone or in combination with one other drug.
Vincristine, etoposide, carboplatin, and cyclophosphamide have been used in many protocols
for brain tumors but the result was very poor in refractory or relapsed cases. However,
irinotecan can be effective with these multiple chemotherapeutic agents. According to the
pilot study of irinotecan in combination with vincristine, etoposide, carboplatin and
cyclophosphamide in the investigators center, 75% percent of total 12 patients reached more
than stable disease, and 2 patients got long term complete remission only with this
multi-agent combination chemotherapy. But the combination of irinotecan, vincristine,
etoposide, carboplatin, and cyclophosphamide is not clinically studied yet especially for
pediatric patients. To improve response rate and progression-free survival, the combination
chemotherapy of irinotecan, vincristine, etoposide, carboplatin, and cyclophosphamide is
designed for pediatric refractory or relapsed brain tumor.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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