Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
|ClinicalTrials.gov Identifier: NCT00005955|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Neuroblastoma||Drug: temozolomide||Phase 2|
- Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors.
- Determine the toxicity of this treatment in these patients.
- Determine the overall survival in these patients for 18 months following the study after receiving this treatment.
OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other).
Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy.
PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy|
|Study Start Date :||August 2000|
|Study Completion Date :||September 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005955
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|