NCT00002944

Combination Chemotherapy in Treating Children With Progressive Brain Tumors

Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 9 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: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.

Detailed description

OBJECTIVES: * Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children with progressive brain tumors. * Estimate tumor response rates to each regimen of chemotherapy in these patients. * Determine toxic effects and quality of life of children treated with each regimen of chemotherapy. * Investigate biological and clinical factors which may predict tumor response and early progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative index by MIB-1 (Ki67)) in these patients. * Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation. OUTLINE: This is a randomized study. Patients are stratified according to site of disease, status at entry, and pathology. Patients are randomized to one of two treatment arms. Patients with neurofibromatosis are nonrandomly assigned to arm II. * Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery. Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently with the first 3 weeks of carboplatin), followed by 2 weeks of rest. * Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4, followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a maximum of 8 courses. PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.

Conditions

• Brain Tumors
• Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	carboplatin	Given IV
DRUG	lomustine	Given IV
DRUG	procarbazine hydrochloride	Given PO
DRUG	thioguanine	Given PO
DRUG	vincristine sulfate	Given PO and IV

Timeline

• Start date: 1997-04-01
• Primary completion: 2006-02-01
• Completion: 2012-04-01
• First posted: 2003-01-27
• Last updated: 2013-09-09

Locations

204 sites across 6 countries: United States, Australia, Canada, Netherlands, New Zealand, Switzerland