A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent
glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and
topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine
survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor
p53 expression in relation to response to TAX/TOPO/G-CSF.
OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2
courses and until 2 courses beyond maximum response. Patients are followed every 3 months
for 2 years, then every 6 months for relapse and survival.
PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the
first 20 patients.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Camilo E Fadul, MD
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|