Spots Global Cancer Trial Database for Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

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Trial Identification

Brief Title: Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Official Title: Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

Study ID: NCT00610571

Conditions

Glioblastoma

Gliosarcoma

Anaplastic Astrocytoma

Interventions

Oral Topotecan and Temodar

Study Description

Brief Summary: 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.

Detailed Description: 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.