Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005955 |
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 | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Neuroblastoma |
Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 4 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Eligible types include the following:
Malignant glioma
At least one bidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Henry S. Friedman, MD | Duke University |
Study ID Numbers: | CDR0000067936, DUMC-0931-02-6R3, DUMC-000931-00-5R1, DUMC-0831-99-5, NCI-G00-1799, DUMC-000931-01-6R1 |
Study First Received: | July 5, 2000 |
Last Updated: | August 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00005955 History of Changes |
Health Authority: | United States: Federal Government |
childhood infratentorial ependymoma childhood low-grade cerebral astrocytoma childhood supratentorial ependymoma childhood craniopharyngioma localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma |
childhood grade II meningioma childhood grade III meningioma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood cerebellar astrocytoma untreated childhood medulloblastoma untreated childhood visual pathway and hypothalamic glioma newly diagnosed childhood ependymoma childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor |
Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Astrocytoma Choriocarcinoma Central Nervous System Neoplasms Temozolomide Neuroblastoma Ependymoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Craniopharyngioma |
Medulloblastoma Neuroepithelioma Oligodendroglioma Meningioma Antineoplastic Agents, Alkylating Glioma Alkylating Agents Teratoma Neuroectodermal Tumors, Primitive, Peripheral Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroblastoma Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |