RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.
OBJECTIVES: * Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival and survival at 6 and 12 months in patients treated with this drug. * Assess pain in patients treated with this drug. * Evaluate the quantitative and qualitative toxic effects of this drug in these patients. * Evaluate the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
Nemours Children's Clinic
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Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
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