A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
- 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 IV over 1 hour once weekly and
involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6
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
PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Jean B. Belasco, MD
Children's Hospital of Philadelphia
United States: Federal Government
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|