drugset / Trial / NCT00458601
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |