drugset / Trial / NCT00629187

Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy

NCT00629187 ↗

Phase 1 Terminated 2 enrolled Tufts Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely be given to subjects with brain tumors. Past studies showed that the maximum dose of temozolomide was limited by low blood counts. The investigators will use blood stem cells collected from bone marrow to help subjects recover their blood counts, a procedure called autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be able to safely deliver very high doses of temozolomide. This study is only available at Tufts Medical Center.

Timeline

Start
2004-04
Primary completion
2012-04
Completion
2012-04

Outcome

Outcome not reported

Stopped (Enrollment): “The study was stopped due to lack of adequate enrollment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 350 mg/m2 Oral
Subject Temozolomide Small molecule 1500 mg/m2 Oral