Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES:
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
patient population.
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
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