drugset / Trial / NCT00458601

Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

NCT00458601

Phase 2 Completed 82 enrolled Celldex Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.

Timeline

Start
2007-08
Primary completion
2010-11
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject rindopepimut Vaccine 500 ug Intrathecal
Background Temozolomide Small molecule 150 mg/m2
Background Temozolomide Small molecule 200 mg/m2
Background sargramostim Protein / enzyme biologic 150 ug Intrathecal

Indications