drugset / Trial / NCT00272870

Treatment of Newly Diagnosed Brain Tumors With Chemotherapy and Radiation Using Cells Modified for Chemoprotection and an Experimental Drug to Decrease the Tumor Cell Resistance to Chemotherapy

NCT00272870 ↗

Phase 1 Terminated 1 enrolled Children's Hospital Medical Center, Cincinnati
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

Cure rates for patients with high grade glioma remain disappointing, in part because tumor cells are often resistant to chemotherapy, and because using higher doses of chemotherapy causes damage to normal blood cells. This trial is designed to try to overcome both of these barriers. The idea is to make tumor cells more sensitive to a chemotherapy agent, Temozolomide, by using 06Benzylguanine (06BG). In addition, patients will have a portion of their blood cells modified by the insertion of a chemotherapy resistance gene which may help protect blood cells from damage by the combination of the Temozolomide and 06BG.

Timeline

Start
2005-12
Primary completion
2008-12
Completion
2012-08

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual; drug availability”

Drugs

EvaluationDrugModalityDoseRoute
Subject 06Benzylguanine Unknown 120 mg/m2 —
Subject MGMTP140K Unknown 1e+07 cells/kg —