We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00045968
Recruitment Status : Active, not recruiting
First Posted : September 19, 2002
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Glioblastoma GBM Grade IV Astrocytoma Glioma Brain Cancer Brain Tumor Drug: Dendritic cell immunotherapy Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2006
Estimated Primary Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. [ Time Frame: Until death ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Until death ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045968

Hide Hide 86 study locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter East Bay Neuroscience Institute-Eden Medical Center
Castro Valley, California, United States, 94546
City of Hope
Duarte, California, United States, 91010
UCSD Moores Cancer Center
La Jolla, California, United States, 93093
Kaiser Permanente - Los Angeles
Los Angeles, California, United States, 90027
UCLA Medical Center
Los Angeles, California, United States, 90095
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
St. Joseph Hospital of Orange
Orange, California, United States, 92868
University of California, Irvine Medical Center
Orange, California, United States, 92868
Kaiser Permanente - Redwood City
Redwood City, California, United States, 94063
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Mount Sinai Community Clinical Oncology Program
Miami Beach, Florida, United States, 33140
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Cadence Cancer Center
Warrenville, Illinois, United States, 60555
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Markey Cancer Center/University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
The Brain Tumor Center at JFK Medical Center
Edison, New Jersey, United States, 08818
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Overlook Hospital
Summit, New Jersey, United States, 07902
Capital Health Regional Medical Center
Trenton, New Jersey, United States, 08638
United States, New York
Long Island Brain Tumor Center at Neurological Surgery, P.C.
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
New York University Clinical Cancer Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Brain and Spine Surgeons of New York and Northern Westchester Hospital
White Plains, New York, United States, 10604
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
Columbus, Ohio, United States, 43214
United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States, 29425
United States, Tennessee
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
The Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Swedish Hospital Neuroscience Research
Seattle, Washington, United States, 98122
United States, Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 23215
Canada, Quebec
Montreal Neurological Institute, McGill University
Montreal, Quebec, Canada, H3A 2B4
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Universitätsklinikum Heidelberg Neurochirurgische Klinik
Heidelberg, Baden-Württemberg, Germany, 69120
Stuttgart, Baden-Württemberg, Germany, 70174
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
Frankfurt, Hesse, Germany, 60528
Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
Bonn, North Rhine-Westphalia, Germany, 53105
Universitätsklinikum Klinik für allgemeine Neurochirurgie
Köln, North Rhine-Westphalia, Germany, 50924
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
Halle, Saxony-Anhalt, Germany, 06112
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany, 01307
Neurochirurgische Klinik
Hamburg, Germany, 20246
United Kingdom
Addenbrookes NHS Trust
Cambridge, Cambridgeshire, East Anglia, United Kingdom, CB2 2QQ
Kings College Hosital NHS Foundation Trust
London, Greater London, United Kingdom, SE5 9RS
University College Hospital London
London, Greater London, United Kingdom, WC1E 6BT
University Hospital of Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, N15 2WB
Sponsors and Collaborators
Northwest Biotherapeutics
Layout table for investigator information
Principal Investigator: Linda Liau, M.D. University of California, Los Angeles
Study Director: Marnix L. Bosch, MBA, PhD Northwest Biotherapeutics
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Erratum In: J Transl Med. 2018 Jun 29;16(1):179.

Layout table for additonal information
Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT00045968    
Other Study ID Numbers: 020221
First Posted: September 19, 2002    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Keywords provided by Northwest Biotherapeutics:
brain tumor
brain cancer
glioblastoma multiforme
newly diagnosed glioblastoma
dendritic cells
immune therapy
Brain cancer, primary
tumor vaccine
grade IV astrocytoma
Grade IV brain cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases