drugset / Trial / NCT01310868

Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma

NCT01310868

Phase 2 Completed 59 enrolled University College, London
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with 5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in treating patients with primary glioblastoma.

Timeline

Start
2011-05
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject carmustine Small molecule Other
Background Temozolomide Small molecule 200 mg/m2

Indications