Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of Oxaliplatin (NSC# 266046, IND #57004) and Irinotecan in Pediatric Patients With Refractory Solid Tumors and Lymphomas
This phase I trial is studying the side effects and best dose of oxaliplatin when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in
pediatric patients with refractory solid tumors or lymphomas.
II. Determine the toxic effects of this regimen in these patients. III. Determine the
pharmacokinetics of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine, preliminarily, the antitumor activity of this regimen in these patients.
II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin.
Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour
on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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