Description
" Purpose 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. Patients randomized to the placebo arm 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) Condition Intervention Phase Glioblastoma Multiforme Glioblastoma GBM Grade IV Astrocytoma Glioma Brain Cancer Brain Tumor Drug: Dendritic cell immunotherapy Phase 3 Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM) Resource links provided by NLM: MedlinePlus related topics: Cancer Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Diffuse Astrocytoma Glioblastoma Glioma Neuroepithelioma Subependymal Giant Cell Astrocytoma U.S. FDA Resources Further study details as provided by Northwest Biotherapeutics: Primary Outcome Measures: The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients. [ Time Frame: Time to tumor progression or death ] [ Designated as safety issue: No ] Secondary Outcome Measures: The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ] [ Designated as safety issue: No ] Estimated Enrollment: 348 Study Start Date: December 2006 Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure) Arms Assigned Interventions Active Comparator: treatment cohort Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120. Other Names: DCVax-L DCVax DCVax-Brain Placebo Comparator: Placebo Chohort Autologous PBMC Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120. Other Names: DCVax-L DCVax DCVax-Brain Detailed Description: This Phase III trial is designed to evaluate the impact on disease progression and survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to ""teach"" the immune system how to recognize brain cancer cells. Eligible patients will receive a series of injections of DCVax-L, to activate and then boost the immune response to the tumor cells. The primary study endpoint is PFS (progression free survival), and the first secondary endpoint is overall survival (OS). Other endpoints include performance status, immune response, and also safety. Interim analyses to assess efficacy are incorporated in the trial design. Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain & swelling at the injection site."
