Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00313521|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 12, 2006
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: thiotepa Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 1995|
|Estimated Primary Completion Date :||November 1997|
- Degree of surgical resection by surgical and radiological assessments
- Tumor response to chemotherapy by imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313521
|Study Chair:||David A. Walker||Queen's Medical Centre|