Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)
Glioblastoma Multiforme, Glioblastoma, GBM
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring oncology, neurology, glioma, brain tumor, brain cancer, glioblastoma multiforme, glioblastoma, newly diagnosed glioblastoma, immunotherapy, dendritic cells, immune therapy, GBM, Brain cancer, primary, tumor vaccine, grade IV astrocytoma, DCVax, Grade IV brain cancer
Eligibility Criteria
Inclusion Criteria: All patients must meet the following inclusion criteria. All tests and eligibility criteria must be completed within four weeks of completion of radiation and chemotherapy, following surgery. Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee. Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process. Subjects ≥18 and ≤70 years of age at surgery who are capable of informed consent. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study. Patients must have a life expectancy of >8 weeks. Patients must have a KPS rating of ≥70 at the baseline visit (Visit 3). Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis. Patients must not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately. Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-L. DCVax-L treatment must be given as described and temozolomide/Temodar treatment schedules must be given essentially according to the Stupp Protocol. Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white blood count 3600-11,000mm3, absolute granulocyte count ≥1,500/mm3, absolute lymphocyte count ≥1,000/mm3, and platelet count ≥100K/mm3. Eligibility level of hemoglobin can be reached by transfusion. Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤1.5 times upper limits of normals (ULN) and total bilirubin ≤1.5mg/dl), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy.
Sites / Locations
- University of Alabama at Birmingham
- University of Arkansas for Medical Sciences
- Sutter East Bay Neuroscience Institute-Eden Medical Center
- City of Hope
- UCSD Moores Cancer Center
- Kaiser Permanente - Los Angeles
- UCLA Medical Center
- Hoag Memorial Hospital Presbyterian
- St. Joseph Hospital of Orange
- University of California, Irvine Medical Center
- Kaiser Permanente - Redwood City
- Sutter Institute for Medical Research
- University of Colorado Cancer Center
- Colorado Neurological Institute
- Georgetown University Medical Center
- University of Florida
- Memorial Cancer Institute
- Mount Sinai Community Clinical Oncology Program
- Moffitt Cancer Center
- Piedmont Atlanta Hospital
- Rush University Medical Center
- Illinois Cancer Care
- Cadence Cancer Center
- IU Simon Cancer Center
- University of Kansas Cancer Center
- Markey Cancer Center/University of Kentucky
- Norton Cancer Institute
- Tufts Medical Center
- Beth Israel Deaconess Medical Center
- University of Michigan Cancer Center
- Henry Ford Hospital
- Spectrum Health
- John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
- St. Luke's Hospital
- Washington University School of Medicine
- The Brain Tumor Center at JFK Medical Center
- John Theurer Cancer Center at Hackensack University Medical Center
- The Valley Hospital
- Overlook Hospital
- Capital Health Regional Medical Center
- Long Island Brain Tumor Center at Neurological Surgery, P.C.
- North Shore University Hospital
- New York University Clinical Cancer Center
- Mount Sinai Medical Center
- Columbia University Medical Center
- University of Rochester Medical Center
- Stony Brook Medicine
- Brain and Spine Surgeons of New York and Northern Westchester Hospital
- University of North Carolina, Chapel Hill
- Wake Forest Baptist Medical Center
- University of Cincinnati Cancer Institute
- University Hospitals Seidman Cancer Center
- Cleveland Clinic Foundation
- Ohio State University
- OhioHealth
- Oklahoma University Health Science Center
- Geisinger Medical Center
- Hospital of the University of Pennsylvania
- Jefferson Hospital for Neuroscience
- Temple University School of Medicine
- Rhode Island Hospital
- Medical University of South Carolina Hospitals and Clinics
- Saint Thomas Research Institute
- Vanderbilt Ingram Cancer Center
- Baylor Research Institute
- The Methodist Hospital
- University of Texas Health Science Center at Houston
- Cancer Therapy & Research at University of Texas Health Science Center San Antonio
- Benaroya Research Institute at Virginia Mason
- Swedish Hospital Neuroscience Research
- Aurora Saint Luke's Medical Center
- Montreal Neurological Institute, McGill University
- CHUS - Hôpital Fleurimont
- Universitätsklinikum Heidelberg Neurochirurgische Klinik
- Katharinenhospital
- Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
- Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
- Universitätsklinikum Klinik für allgemeine Neurochirurgie
- BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
- Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
- Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
- Neurochirurgische Klinik
- Addenbrookes NHS Trust
- Kings College Hosital NHS Foundation Trust
- University College Hospital London
- University Hospital of Birmingham NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
treatment cohort
Placebo Chohort
Autologous PBMC