Expired Study
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Durham, North Carolina 27710


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. 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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00005955


Primary Contact:

Study Chair
Henry S. Friedman, MD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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