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

Phase 1

Terminated

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00031577
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed 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 Timeline

• Study Start: 1999-08
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2014-01
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Winship Cancer Institute of Emory University; 🇺🇸 Egleston, Georgia, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States