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
Duke University
With
OBJECTIVES: * Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors. * Evaluate the toxicity of this treatment in these patients. * Determine the activity of this treatment in these patients. OUTLINE: This is a dose escalation study of temozolomide. Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. 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 at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for 1-3 years, then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
