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Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors Clinical research trials and Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors. Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors  Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
For Condition: childhood brain tumor,childhood nerve tumor
Status: No longer recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 4 Years/21 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000067936; DUMC-0931-02-6R3,DUMC-0831-99-5,DUMC-000931-00-5R1,DUMC-000931-01-6R1,NCI-G00-1799
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005955
Other Childhood Brain Tumor Studies:
1. Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Related Studies:
Other childhood brain tumor Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
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