Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

Conditions
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Brain and Central Nervous System Tumors, Neuroblastoma

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy Patients with diffuse pontine tumors do not require histological confirmation Eligible types include the following: Ependymoma Malignant glioma Anaplastic astrocytoma Glioblastoma multiforme Anaplastic oligodendroglioma Gliosarcoma Anaplastic mixed oligoastrocytoma Brainstem glioma Primitive neuroectodermal tumor Nongerminoma germ cell tumor At least one bidimensionally measurable lesion At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days after surgery Diffuse pontine tumors are not required to be measurable Neurologically stable PATIENT CHARACTERISTICS: Age: 4 to 21 Performance status: Karnofsky or Lansky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN SGOT and SGPT less than 2.5 times ULN Renal: BUN and creatinine less than 1.5 times ULN Other: Must be able to swallow capsules No acute infection treated with intravenous antibiotics No nonmalignant systemic disease that makes patient a poor medical risk No frequent vomiting or medical condition that may interfere with oral medication intake (e.g., partial bowel obstruction) No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than one prior biologic therapy regimen No concurrent biologic therapy No concurrent growth factors or epoetin alfa Chemotherapy: No more than one prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: No increasing doses of steroids within one week of study Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks, but no greater than 4 weeks, since prior surgical resection and recovered Other: No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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