Clinical Trial: Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors.
Detailed Summary:
OBJECTIVES:
Primary
- Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors.
Secondary
- 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 gliosarcoma.
- Determine the incidence of distant neuraxial metastases in patients at the time of relapse.
- 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 age).
- 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
Sponsor: Children's Cancer and Leukaemia Group
Current Primary Outcome: Degree of surgical resection by surgical and radiological assessments
Original Primary Outcome:
Current Secondary Outcome: Tumor response to chemotherapy by imaging
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: April 11, 2006
Date Started: June 1995
Date Completion:
Last Updated: September 19, 2013
Last Verified: December 2006