Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Children's Oncology Group
With
OBJECTIVES: Primary * Determine the response rate in pediatric patients with relapsed neuroblastoma (NB) treated with irinotecan hydrochloride and temozolomide. * Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen. Secondary * Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy. * Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients. * Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies. * Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis. * Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis. OUTLINE: This is a multicenter study. Patients are stratified according to disease status (measurable disease \[measured by conventional CT scan and/or MRI\] vs evaluable disease \[tumor detected by conventional morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on MIBG scan\]). Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 10 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
