Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
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 with
refractory or advanced solid tumors who are receiving anticonvulsants.
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan in children with refractory or
advanced solid tumors receiving anticonvulsants.
- Determine the dose-limiting toxicity of irinotecan in this patient population.
- Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.
- Determine, preliminarily, the antitumor activity of this treatment regimen in these
patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs
other anticonvulsants).
Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days
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) is reached. The MTD is defined as the dose preceding that at which at least 2 of
3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for up to 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
;
Primary Purpose: Treatment
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