High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Brain and Central Nervous System Tumors Clinical Trial

Official title: Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.

Secondary

• Assess the reasons why primary surgery was complete/incomplete in these patients.

• Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.

OUTLINE: This is a multicenter, open-label study.

Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.

After completion of study treatment, patients are followed periodically for 9 years.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Nervous System Neoplasms

• NCT number: NCT00287924
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2005