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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Northwest Biotherapeutics Identifier:
First received: September 17, 2002
Last updated: October 29, 2015
Last verified: October 2015
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
Grade IV Astrocytoma
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:

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00045968

  Hide Study Locations
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
St. 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
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
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
New York University Clinical Cancer Center
New York, New York, United States, 10016
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
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
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
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
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
Principal Investigator: Linda Liau, M.D. University of California, Los Angeles
Study Director: Marnix L. Bosch, MBA, PhD Northwest Biotherapeutics
  More Information

Additional Information:
No publications provided by Northwest Biotherapeutics

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Northwest Biotherapeutics Identifier: NCT00045968     History of Changes
Other Study ID Numbers: 020221
Study First Received: September 17, 2002
Last Updated: October 29, 2015
Health Authority: United States: Food and Drug Administration

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:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors processed this record on November 25, 2015