Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
NCT ID: NCT00045968
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
348 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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treatment cohort
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.
Placebo Chohort
Autologous PBMC
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Northwest Biotherapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Linda Liau, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Marnix L. Bosch, MBA, PhD
Role: STUDY_DIRECTOR
Northwest Biotherapeutics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter East Bay Neuroscience Institute-Eden Medical Center
Castro Valley, California, United States
City of Hope
Duarte, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Kaiser Permanente - Los Angeles
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, 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
Sutter Institute for Medical Research
Sacramento, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Mount Sinai Community Clinical Oncology Program
Miami Beach, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Cadence Cancer Center
Warrenville, Illinois, United States
IU Simon Cancer Center
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Markey Cancer Center/University of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, 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
Overlook Hospital
Summit, New Jersey, United States
Capital Health Regional Medical Center
Trenton, New Jersey, United States
Long Island Brain Tumor Center at Neurological Surgery, P.C.
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
New York University Clinical Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Brain and Spine Surgeons of New York and Northern Westchester Hospital
White Plains, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
OhioHealth
Columbus, Ohio, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
Swedish Hospital Neuroscience Research
Seattle, Washington, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Montreal Neurological Institute, McGill University
Montreal, Quebec, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Universitätsklinikum Heidelberg Neurochirurgische Klinik
Heidelberg, Baden-Wurttemberg, Germany
Katharinenhospital
Stuttgart, Baden-Wurttemberg, Germany
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Klinik für allgemeine Neurochirurgie
Cologne, North Rhine-Westphalia, Germany
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
Halle, Saxony-Anhalt, Germany
Neurochirurgische Klinik
Hamburg, , 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
Countries
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References
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Liau LM, Ashkan K, Brem S, Campian JL, Trusheim JE, Iwamoto FM, Tran DD, Ansstas G, Cobbs CS, Heth JA, Salacz ME, D'Andre S, Aiken RD, Moshel YA, Nam JY, Pillainayagam CP, Wagner SA, Walter KA, Chaudhary R, Goldlust SA, Lee IY, Bota DA, Elinzano H, Grewal J, Lillehei K, Mikkelsen T, Walbert T, Abram S, Brenner AJ, Ewend MG, Khagi S, Lovick DS, Portnow J, Kim L, Loudon WG, Martinez NL, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Giglio P, Gligich O, Krex D, Lindhorst SM, Lutzky J, Meisel HJ, Nadji-Ohl M, Sanchin L, Sloan A, Taylor LP, Wu JK, Dunbar EM, Etame AB, Kesari S, Mathieu D, Piccioni DE, Baskin DS, Lacroix M, May SA, New PZ, Pluard TJ, Toms SA, Tse V, Peak S, Villano JL, Battiste JD, Mulholland PJ, Pearlman ML, Petrecca K, Schulder M, Prins RM, Boynton AL, Bosch ML. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial. JAMA Oncol. 2023 Jan 1;9(1):112-121. doi: 10.1001/jamaoncol.2022.5370.
Liau LM, Ashkan K, Tran DD, Campian JL, Trusheim JE, Cobbs CS, Heth JA, Salacz M, Taylor S, D'Andre SD, Iwamoto FM, Dropcho EJ, Moshel YA, Walter KA, Pillainayagam CP, Aiken R, Chaudhary R, Goldlust SA, Bota DA, Duic P, Grewal J, Elinzano H, Toms SA, Lillehei KO, Mikkelsen T, Walbert T, Abram SR, Brenner AJ, Brem S, Ewend MG, Khagi S, Portnow J, Kim LJ, Loudon WG, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Lindhorst S, Lutzky J, Sloan AE, Schackert G, Krex D, Meisel HJ, Wu J, Davis RP, Duma C, Etame AB, Mathieu D, Kesari S, Piccioni D, Westphal M, Baskin DS, New PZ, Lacroix M, May SA, Pluard TJ, Tse V, Green RM, Villano JL, Pearlman M, Petrecca K, Schulder M, Taylor LP, Maida AE, Prins RM, Cloughesy TF, Mulholland P, Bosch ML. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018 May 29;16(1):142. doi: 10.1186/s12967-018-1507-6.
Badhiwala J, Decker WK, Berens ME, Bhardwaj RD. Clinical trials in cellular immunotherapy for brain/CNS tumors. Expert Rev Neurother. 2013 Apr;13(4):405-24. doi: 10.1586/ern.13.23.
Related Links
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Northwest Biotherapeutics, Inc.
Other Identifiers
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020221
Identifier Type: -
Identifier Source: org_study_id
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