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Home > "C" Clinical Trials Conditions > Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma  Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
For Condition: Childhood Oligodendroglioma,untreated childhood visual pathway glioma,low-grade childhood cerebral astrocytoma,untreated childhood cerebellar astrocytoma
Status: No longer recruiting
Sponsor(s): Societe Internationale d'Oncologie Pediatrique ,
Synopsis: RATIONALE: Drugs used in chemotherapy use 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: Randomized phase III trial to compare the effectiveness of carboplatin plus vincristine in treating children and adolescents with low grade glioma.
Details: OBJECTIVES: I. Develop a standardized scheme of therapy for children and adolescents with low grade glioma. II. Determine the effectiveness of carboplatin and vincristine in treating children aged less than 5 years with severe or progressive symptoms or unequivocal imaging evidence of tumor growth. PROTOCOL OUTLINE: A complete resection of tumor is performed on patients with low grade glioma with or without neurofibromatosis type 1. Surgery is reconsidered following tumor relapse, progression, or clinical deterioration. Every effort is made to obtain a biopsy from patients not receiving debulking surgery. Nonoperative patients and postoperative patients who are not candidates for second surgery receive chemotherapy or radiotherapy. Postoperative patients receive radiotherapy following surgical wound healing and within 28 days of resection. Children less than 5 years old receive chemotherapy first, then radiotherapy if the tumor subsequently progresses or recurs. All other patients receive radiotherapy, then chemotherapy. The latter treatment is conducted in the presence of tumor progression. Chemotherapy is given in 2 parts, first an initial intensive phase (phase 1), then a later continuation phase (phase 2). In phase 1, patients receive vincristine IV weekly for 10 weeks and carboplatin IV every 3 weeks. In phase 2, patients receive vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks. Chemotherapy continues until disease progression or unacceptable toxicity. Patients receive radiotherapy daily 5 times a week. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study over 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /15 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Patients with or without neurofibromatosis type 1 (NF1) with low grade glioma not previously treated with chemotherapy or radiotherapy - Tumor types considered are: Low grade astrocytoma (Kernohan grade 1/2); Oligodendroglioma; Mixed oligoastrocytoma Ganglioglioma - Patients with NF1 and hypothalamic/visual pathway glioma are eligible without biopsy - All CNS sites are eligible, including biopsy proven low grade spinal tumors and intrinsic brain stem tumors - No malignant (anaplastic) glioma (Kernohan grade 3/4), glioblastoma multiforme, and ependymal tumors --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: Not specified --Patient Characteristics-- - Age: Under 16 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidWalker, Study Chair, Societe Internationale d'Oncologie Pediatrique
Zentralklinikum Augsburg
Augsburg, , DOH-8-6156
Germany
University of Padua
Padua, , 35128
Italy
Queen's Medical Centre
Nottingham, England, NG7 2UH
United Kingdom
Additional Information:
Study ID Numbers: CDR0000065595; SIOP-95-2,EU-96063
Study Start Date: January 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003015
Other Untreated Childhood Visual Pathway Glioma Studies:
1. Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
2. Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
Related Studies:
Other untreated childhood visual pathway glioma Clinical Trials
Other Clinical Trials
Other Padua Clinical Trials
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
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