A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
- 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.
Primary Purpose: Treatment
Overall response at 12 months
Henry S. Friedman, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|