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 temozolomide when administered with lomustine in patients with high-grade malignant gliomas. * Determine the dose-limiting toxic effects of this regimen in these patients. * Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population. * Evaluate the radiographic responses in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of temozolomide. Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment continues every 28 days, if blood counts have recovered, for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy. Cohorts of 3-6 patients receive escalating doses of temozolomide 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. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
