drugset / Trial / NCT01044966

A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma

NCT01044966

Phase 1/2 Terminated 12 enrolled Medical University of South Carolina
NaSingle-groupOpen-labelTreatment

Summary

Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.

Timeline

Start
2009-09
Primary completion
2013-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 50 mg Intrathecal
Subject Temozolomide Small molecule 75 mg/m2 Oral