Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who
have refractory or progressive solid tumors.
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in
children with refractory or progressive solid tumors.
- Determine the pharmacokinetics of this drug and its metabolites (SN-38, SN-38G, and
APC) administered with and without concurrent anticonvulsants in this patient
population.
- Determine the benefit this drug offers this patient population.
OUTLINE: This is a dose-escalation, multicenter study. Patients are accrued into stratum 1
initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of
myelosuppression or diarrhea. Patients on anticonvulsants will be accrued into stratum 3 and
must meet the eligibility criteria for the stratum that is open (stratum 1 or stratum 2).
(Stratum 1 closed as of 2002-09-15).
Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6
weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) with and without anticonvulsants is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.
;
Primary Purpose: Treatment
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