NCT00610571

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Katy Peters · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Gliosarcoma
• Anaplastic Astrocytoma

Interventions

Type	Name	Description
DRUG	Oral Topotecan and Temodar	Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day. Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.

Timeline

• Start date: 2004-04-01
• Primary completion: 2009-09-01
• Completion: 2012-04-01
• First posted: 2008-02-08
• Last updated: 2013-10-25

Locations

1 site across 1 country: United States