Glioblastoma Clinical Trial
Official title:
Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
Objectives:
- To determine the maximum tolerated dose of oral topotecan when administered with
Temodar to patients with malignant glioma
- To characterize any toxicity associated with the combination oral topotecan and
Temodar.
- To observe patients for clinical antitumor response when treated with oral topotecan
and Temodar.
Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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