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Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma Clinical research trials and Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma. Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma clinical trial. Subjects typically recieve the finest healthcare available for their Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma  Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
For Condition: untreated childhood visual pathway and hypothalamic glioma,Childhood Oligodendroglioma,untreated childhood cerebellar astrocytoma,childhood spinal cord tumors,low-grade childhood cerebral astrocytoma
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Pilot study to determine the effectiveness of combining carboplatin and vincristine with temozolomide in treating children who have progressive and/or symptomatic low-gradeglioma.
Details: OBJECTIVES: Primary - Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas. Secondary - Determine response rate in patients treated with this regimen. - Determine 3-year progression-free survival and overall survival of patients treated with this regimen. - Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen. OUTLINE: This is a pilot, multicenter study. - Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 36-40. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. - Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /10 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following: - WHO grade I or II astrocytoma - Grade I or II oligodendrogliomas - Mixed oligodendrogliomas - Gangliogliomas - Measurable disease - Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed - Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome - Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms) - No diffuse brain stem tumors - No type 1 neurofibromatosis PATIENT CHARACTERISTICS: Age - 10 and under Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - ALT < 2.5 times ULN Renal - Creatinine clearance or radioisotope glomerular filtration rate 70 mL/min OR - Creatinine 0.8 mg/dL (age 5 and under) OR 1.0 mg/dL (age 6 to10) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunomodulating agents Chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - Prior corticosteroids allowed - No concurrent corticosteroids except for the treatment of increased intracranial pressure Radiotherapy - Not specified Surgery - See Disease Characteristics - Prior surgery allowed Other - No other prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MuraliChintagumpala, Study Chair, Texas Children's Cancer Center
Additional Information:
Study ID Numbers: CDR0000350005; COG-ACNS0223
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077207
Other Childhood Oligodendroglioma Studies:
1. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
2. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
3. Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
4. Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
5. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
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Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
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