Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
I. Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.
II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this
III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and
pharmacokinetic parameters of this regimen in these patients.
OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs
neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas
and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs
other CNS tumors).
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter until death or
until patient enters another POG study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (PR or CR), recorded according to standard solid tumor response criteria
Up to 8 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|