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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
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 Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma |
| Study Start Date: | December 2002 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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| Study Chair: | Kenneth J. Cohen, MD, MBA | Sidney Kimmel Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00028795 History of Changes |
| Other Study ID Numbers: | CDR0000069135, COG-ACNS0126 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
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childhood brain stem glioma childhood high-grade cerebral astrocytoma childhood spinal cord neoplasm untreated childhood brain stem glioma |
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Astrocytoma Glioma Nervous System Neoplasms Central Nervous System Neoplasms Glioblastoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |