Trial Information

Ultimate Low Grade Glioma Study

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.