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A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)
Details
| Lead sponsor | Northwest Biotherapeutics |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 348 |
| Start date | 2006-12 |
Conditions
- Glioblastoma Multiforme
- Glioblastoma
- GBM
- Grade IV Astrocytoma
- Glioma
- Brain Cancer
- Brain Tumor
Interventions
- Dendritic cell immunotherapy
Primary outcomes
- The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma. — Until death
Countries
United States, Canada, Germany, United Kingdom