Clinical Trial: Irinotecan in Treating Children With Refractory Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial of Irinotecan in Children With Refractory Solid Tumors

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome: Objective response (PR or CR), recorded according to standard solid tumor response criteria [ Time Frame: Up to 8 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Toxicity, graded using the NCI CTCAE version 2.0 [ Time Frame: Up to 8 years ]
  • Pharmacokinetics of irinotecan hydrochloride [ Time Frame: Day 1 of course 1 ]


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: December 10, 1999
Date Started: October 1999
Date Completion:
Last Updated: June 13, 2013
Last Verified: June 2013