At a glance
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A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme
In Brief
A Phase 2 clinical trial evaluating Thalidomide, CPT-11, and 2 other interventions for Glioblastoma Multiforme and Glioma. Completed, enrolled 78 participants across 1 site.
Detailed Summary
Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. 1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11. 1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas. 1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.
Study Details
Timeline
Interventions
100 mg PO (by mouth) daily for 8 weeks
125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest
Dynamic MRI scan with dye injection through vein, every 6 weeks
QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.