Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title: A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood

Status Terminated

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.

Clinical Trial Description

OBJECTIVES:

• Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed, diffuse, intrinsic brain stem glioma.

• Determine the toxicity of this regimen in these patients.

• Assess the antitumor activity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.

Patients receive induction therapy comprising paclitaxel intravenously (IV) over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks.

Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study within 12-18 months. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00031577
• Study type: Interventional
• Source: Children's Hospital of Philadelphia
• Status: Terminated
• Phase: Phase 1
• Start date: August 1999
• Completion date: September 2006