Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors

Summary

The specific purpose of this study is to obtain data on safety and efficacy of combination chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall survival and progression-free survival of this regimen, time to progression of the brain metastases, and assessment of toxicity levels in this regimen.

Timeline

Start

2007-03

Primary completion

2014-11

Completion

2014-11

Outcome

Outcome not reported

Stopped (Enrollment): “No enrollment and PI requested study termination per IRB system.”

Drugs

Indications