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Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor Clinical research trials and Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor clinical trial. Subjects often receive the most expert healthcare possible for their Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor  Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
For Condition: Childhood Oligodendroglioma,untreated childhood brain stem glioma,high-grade childhood cerebral astrocytoma,untreated childhood cerebellar astrocytoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , St. Jude Children's Research Hospital
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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor.
Details: OBJECTIVES: I. Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease, and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease. II. Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide. III. Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population. PROTOCOL OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan and if appropriate, patients may undergo a second surgical resection. Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection, patients receive image guided external beam radiotherapy 5 days per week for 6 weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost radiosurgery. At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5 days. Treatment repeats every 3 weeks for 6 courses. Patients are followed every 3 months for 2 years, then every 4 months for 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed newly diagnosed brain tumors - Grade III or IV disease: *Glioblastoma multiforme *Anaplastic astrocytoma *Anaplastic oligodendroglioma *Anaplastic pleomorphic xanthoastrocytoma *Anaplastic or malignant oligoastrocytoma *Gemistocytic astrocytoma *Malignant glioma OR - Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement) OR - Diffuse pontine gliomas with greater than 2/3 involvement of the pons --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: No prior radiotherapy Surgery: No more than 28 days since prior definitive surgery for brain tumor Other: Concurrent anticonvulsants allowed --Patient Characteristics-- Age: 3 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: - WBC greater than 2,500/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 8.0 g/dL Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT less than 5 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmarGajjar, Study Chair, St. Jude Children's Research Hospital
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Additional Information:
Study ID Numbers: CDR0000067271; SJCRH-SJHG98,NCI-G99-1577,SPRI-P-00112
Study Start Date: March 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004068
Other Untreated Childhood Brain Stem Glioma Studies:
1. Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
2. Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
3. Imatinib Mesylate With or Without Radiation Therapy in Treating Children With Newly Diagnosed or Recurrent Glioma
4. Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, or Gliosarcoma
5. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
Related Studies:
Other untreated childhood brain stem glioma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
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