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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028795 |
Purpose
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. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: adjuvant therapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Temozolomide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma |
| Study Start Date: | December 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *For patients with diffuse intrinsic pontine glioma only
Patients are followed every 3-6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
Eligibility
| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed CNS tumor of the following types:
High grade glioma (HGG) of one of the following histologies:
Diffuse intrinsic pontine glioma (DIPG)
No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 230 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Kenneth J. Cohen, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000069135, COG-ACNS0126 |
| First Received: | January 4, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028795 |
| Health Authority: | United States: Federal Government |
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