Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups
- Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric
patients with newly diagnosed malignant astrocytic tumors.
- Determine the acute and chronic toxicity of thiotepa in these patients.
- Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal
fluid pharmacokinetics of thiotepa and tepa in these patients.
- Develop a phase II study framework model, to determine the chemosensitivity to new,
single-agent regimens in the treatment of high-grade (malignant) astrocytic tumors,
including anaplastic astrocytoma, glioblastoma, giant cell glioblastoma, and
- Determine the incidence of distant neuraxial metastases in patients at the time of
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by age (3-15 vs 16-20 years of
- Chemotherapy: Patients receive thiotepa IV continuously over 168 hours on days 1-7.
Treatment repeats every 28 days for up to 2 courses. Patients then proceed to
radiotherapy after blood counts recover.
- Radiotherapy: Patients undergo external-beam radiotherapy once daily, 5 days a week,
for approximately 6 weeks.
- Post-radiation chemotherapy: Patients with complete, partial, or objective response, or
stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more
courses at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Degree of surgical resection by surgical and radiological assessments
David A. Walker
Queen's Medical Centre
United States: Federal Government