Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Children's Oncology Group
With
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.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
