NCT00003015

Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma

Ultimate Low Grade Glioma Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Societe Internationale d'Oncologie Pediatrique · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. 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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	vincristine sulfate
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 1997-01-01
• First posted: 2004-05-27
• Last updated: 2013-12-04

Locations

3 sites across 3 countries: Germany, Italy, United Kingdom