Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
- Conditions
- Grade IV AstrocytomaBrain CancerGlioblastomaGliomaBrain TumorGlioblastoma MultiformeGBM
- Interventions
- Drug: Dendritic cell immunotherapy
- Registration Number
- NCT00045968
- Lead Sponsor
- Northwest Biotherapeutics
- Brief Summary
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)
- Detailed Description
This Phase III trial is designed to evaluate the impact on 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 OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma.
Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain \& swelling at the injection site.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 348
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment cohort Dendritic cell immunotherapy - Placebo Chohort Dendritic cell immunotherapy Autologous PBMC
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM. Until death
Trial Locations
- Locations (86)
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Sutter East Bay Neuroscience Institute-Eden Medical Center
🇺🇸Castro Valley, California, United States
City of Hope
🇺🇸Duarte, California, United States
Kaiser Permanente - Los Angeles
🇺🇸Los Angeles, California, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Kaiser Permanente - Redwood City
🇺🇸Redwood City, California, United States
Memorial Cancer Institute
🇺🇸Hollywood, Florida, United States
Mount Sinai Community Clinical Oncology Program
🇺🇸Miami Beach, Florida, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Cadence Cancer Center
🇺🇸Warrenville, Illinois, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
The Brain Tumor Center at JFK Medical Center
🇺🇸Edison, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Long Island Brain Tumor Center at Neurological Surgery, P.C.
🇺🇸Lake Success, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
New York University Clinical Cancer Center
🇺🇸New York, New York, United States
Brain and Spine Surgeons of New York and Northern Westchester Hospital
🇺🇸White Plains, New York, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth
🇺🇸Columbus, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Jefferson Hospital for Neuroscience
🇺🇸Philadelphia, Pennsylvania, United States
Temple University School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
CHUS - Hôpital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Katharinenhospital
🇩🇪Stuttgart, Baden-Württemberg, Germany
Montreal Neurological Institute, McGill University
🇨🇦Montreal, Quebec, Canada
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
🇩🇪Frankfurt, Hesse, Germany
Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
🇩🇪Bonn, North Rhine-Westphalia, Germany
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
🇩🇪Halle, Saxony-Anhalt, Germany
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Saxony, Germany
Neurochirurgische Klinik
🇩🇪Hamburg, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
🇩🇪Dresden, Saxony, Germany
Addenbrookes NHS Trust
🇬🇧Cambridge, Cambridgeshire, East Anglia, United Kingdom
Kings College Hosital NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
University College Hospital London
🇬🇧London, Greater London, United Kingdom
University Hospital of Birmingham NHS Foundation Trust
🇬🇧Birmingham, West Midlands, United Kingdom
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospitals Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Swedish Hospital Neuroscience Research
🇺🇸Seattle, Washington, United States
IU Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
Universitätsklinikum Klinik für allgemeine Neurochirurgie
🇩🇪Köln, North Rhine-Westphalia, Germany
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Universitätsklinikum Heidelberg Neurochirurgische Klinik
🇩🇪Heidelberg, Baden-Württemberg, Germany
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
University of Michigan Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma University Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical University of South Carolina Hospitals and Clinics
🇺🇸Charleston, South Carolina, United States
Markey Cancer Center/University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Capital Health Regional Medical Center
🇺🇸Trenton, New Jersey, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States