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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Northwest Biotherapeutics
Information provided by (Responsible Party):
Northwest Biotherapeutics Identifier:
First received: September 17, 2002
Last updated: June 26, 2015
Last verified: June 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: 300
Study Start Date: December 2006
Estimated Primary Completion Date: September 2015 (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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00045968

Contact: Marnix L Bosch, MBA, PhD 240-497-9022

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Cathie Robinson    205-934-2921   
Principal Investigator: James Markert, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Shana Fetters    501-686-8274   
Principal Investigator: Shirley Ong, MD         
United States, California
Sutter East Bay Neuroscience Institute-Eden Medical Center Active, not recruiting
Castro Valley, California, United States, 94546
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Alexandra Ching    866-235-3031   
Principal Investigator: Jana Portnow, MD         
St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Deborah Yoon, RN, SC    714-446-5364   
Principal Investigator: William Loudon, MD         
UCI Medical Center Recruiting
Irvine, California, United States, 92868
Contact: Oliver John Quines    714-456-6907   
Principal Investigator: Daniela Bota, MD         
UCSD Moores Cancer Center Active, not recruiting
La Jolla, California, United States, 93093
Kaiser Permanente - Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sandra Baker-Bolden    323-783-5532   
Principal Investigator: Richard M. Green, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Billingslea-Yoon, R.N.    310-267-2621   
Principal Investigator: Linda Liau, MD, PhD         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Robin Ellis    949-764-5543   
Principal Investigator: Christopher Duma, MD         
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Andrew Holman    714-734-6200 ext 40842   
Principal Investigator: William Loudon, MD         
Kaiser Permanente - Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Nancy Mendelssohn    650-299-4165   
Principal Investigator: Victor Tse, MD         
Sutter Institute for Medical Research Recruiting
Sacramento, California, United States, 95816
Contact: Natalie Marlen, CCRC    916-453-5742   
Principal Investigator: Stacy D'Andre, M.D.         
South Pasadena Cancer Center Recruiting
South Pasadena, California, United States, 91030
Contact: Julie Kilpatrick, RN    626-256-4673   
Principal Investigator: Jana Portnow, MD         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Monica Robischon    720-848-0661   
Principal Investigator: Kevin Lillehei, MD         
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Alicia Novak    303-357-5446   
Principal Investigator: Micheal Pearlman, MD         
United States, District of Columbia
Georgetown University Medical Center Completed
Washington, District of Columbia, United States, 20057
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Whitney McNeal Chapman, RN    352-273-7774   
Principal Investigator: David Tran, MD         
Memorial Cancer Institute Active, not recruiting
Hollywood, Florida, United States, 33021
Mount Sinai CCOP Recruiting
Miami Beach, Florida, United States, 33140
Contact: Leandro Pisano    305-674-2625 ext 55629   
Principal Investigator: Jose Lutzky, MD         
Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Michelle Humphreys    404-425-7943   
Principal Investigator: Erin Dunbar, MD         
Emory University, Winship Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
University of Illinois Medical Center Withdrawn
Chicago, Illinois, United States, 60612
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
Contact: Carrie Margis    309-243-3621   
Principal Investigator: Francois Geoffroy, MD         
Central DuPage Cancer Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Claudine Gamster    630-315-1918   
Principal Investigator: Sean Grimm, MD         
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Funke    317-278-0328   
Principal Investigator: Stephanie Wagner, MD         
United States, Kansas
KU Medical Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Ashley Shores    913-588-1897   
Principal Investigator: Sarah Taylor, M.D.         
United States, Kentucky
Markey Cancer Center/University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Helena Yoder    312-996-9240   
Principal Investigator: John Villano, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Janlyn Murphy    617-667-1832   
Principal Investigator: David Avigan, MD         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amy Quinkert    617-636-8589   
Principal Investigator: Julian Wu, MD         
United States, Michigan
University of Michigan, Department of Neurosurgery Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Frisch    734-232-4843   
Contact: Adam Booth    734-615-1749   
Principal Investigator: Jason Heth, M.D.         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Leon, RN    313-916-6781   
Principal Investigator: Tom Mikkelsen, MD         
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Marianne Morrissey    616-391-1129   
Principal Investigator: Wendy Sherman, MD         
United States, Minnesota
John Nasseff Neuroscience Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Nilanjana Banerji    612-262-4837 ext na.Baner   
Principal Investigator: John Trusheim, M.D.         
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jennifer McIntire, RN    816-932-7985   
Principal Investigator: Darren Lovick, MD         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Abigail Gwinn    314-747-4678   
Principal Investigator: Jian Campian, MD         
United States, New Jersey
JFK Brain Tumor Center Recruiting
Edison, New Jersey, United States, 08820
Contact: Charles Porbeni    732-321-8897   
Principal Investigator: Joseph C Landolfi, MD         
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Cappello    201-996-5098   
Principal Investigator: Samuel Goldlust, MD         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Patricia Eagan, RN    908-522-5843   
Principal Investigator: Michael L Gruber, MD         
Capital Health Regional Medical Center Recruiting
Trenton, New Jersey, United States, 08638
Contact: Cynthia Lewis-Diaz    609-394-6287   
Principal Investigator: Arlan Mintz, MD         
United States, New York
Huntington Hospital Recruiting
Huntington, New York, United States, 11743
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010   
Principal Investigator: Jai Grewal, MD         
Long Island Brain Tumor Centre at Neurological Surgery P.C. Recruiting
Lake Success, New York, United States, 11042
Contact: Kimberly Prabhu, MA, CCRP    631-864-3900   
Principal Investigator: Jai Grewal, MD         
North Shore Health System Recruiting
Lake Success, New York, United States, 11042
Contact: Louise Purcell    516-941-1263   
Principal Investigator: Michael Schulder, MD         
North Shore University Hospital Active, not recruiting
Manhasset, New York, United States, 11030
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Kimberly Prabhu    516-478-0010   
Principal Investigator: Jai Grewal, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christina Corpuz    212-342-2959   
Principal Investigator: Fabio Iwamoto, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029-6574
Contact: Elana Pessin    212-241-5698   
Principal Investigator: Adilia Hormigo, MD         
New York University Clinical Cancer Center Completed
New York, New York, United States, 10016
South Nassau Community Hospital Recruiting
Oceanside, New York, United States, 11572
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010   
University of Rochester Medical Center Active, not recruiting
Rochester, New York, United States, 14642
Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11571-9024
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010   
Principal Investigator: Jai Grewal, MD         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Susan Fiore, M.S.    631-444-9425   
Principal Investigator: Raphael Davis, M.D.         
New York Medical College Active, not recruiting
Valhalla, New York, United States, 10595
Brain and Spine Surgeons of New York and Northern Westchester Hospital Active, not recruiting
White Plains, New York, United States, 10604
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Wasi Khan, PhD    919-843-9499   
Principal Investigator: Matthew Ewend, MD         
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jennifer MacLean    336-713-6915   
Principal Investigator: Glenn Lesser, MD         
United States, Ohio
University of Cincinnati Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Suzanne Sifri, RN, BSN    513-584-0618   
Principal Investigator: Richard Curry, MD         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Gina Cascone, RN    216-983-3021   
Principal Investigator: Andrew E. Sloan, MD         
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Aubrey Hastings    614-293-8607   
Contact    Fax: +1-614-293-4345      
Principal Investigator: J. Bradley Elder, MD         
United States, Oklahoma
Oklahoma University Health Science Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Riza Fabreo    405-271-8777   
Principal Investigator: James Battiste, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Angela Whitmire    570-214-9603   
Principal Investigator: Steven Toms, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Suzanne Frangos, RN, CNRN    215-285-2885   
Contact: Dept. of Neurosurgery    (215) 615-5436   
Principal Investigator: Steven Brem, MD         
Temple University School of Medicine Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Wendy Turchetti    401-444-7740   
Principal Investigator: Heinrich Elinzano, MD         
United States, South Carolina
Medical University of South Carolina Hospitals and Clinics Recruiting
Charleston, South Carolina, United States, 29425
Contact: Michele DeCandio    843-792-9016   
Principal Investigator: Scott Lindhorst, MD         
United States, Tennessee
St. Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Nancy Grimes, RN    615-222-4356   
Principal Investigator: Steve Abram, MD         
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Katy Lyons, RN BSN CCRC    800-811-8480   
Principal Investigator: Reid Thompson, MD         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Valerie Clark    214-820-6168   
Principal Investigator: Karen Fink, MD, PhD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lenis Sosa, BSN, RN, OCN    713-441-3245   
Principal Investigator: David Baskin, MD         
Yvonne Kew, MD, PhD, Neuro-Oncology Clinic Withdrawn
Houston, Texas, United States, 77030
Cancer Therapy & Research at University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Laura Garcia    210-450-5964   
Principal Investigator: Andrew Brenner, MD, PhD         
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Contact: Leila Ponce    206-342-6926   
Principal Investigator: Lynne Taylor, MD         
Swedish Hospital Neuroscience Research Recruiting
Seattle, Washington, United States, 98122
Contact: Nathan Hansen    206-320-3542   
Principal Investigator: Charles Cobbs, M.D.         
United States, Wisconsin
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 23215
Contact: Lynda Yanny    414-649-6685   
Principal Investigator: George Bobustuc, MD         
Canada, Quebec
Montreal Neurological Institute, McGill University Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Lisa Nezvitsky    +1-514-398-2667   
Principal Investigator: Kevin Petrecca, MD, PhD, FRCS(C)         
CHUS - Hôpital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Anick Champoux    819-346-1110 Ext. 12811   
Principal Investigator: David Mathieu, M.D., F.R.C.S.(C)         
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Saxony, Germany
Contact: Andrea Sorokin    +49 (0) 351 458 18157   
Principal Investigator: Gabriele Schackert, Prof, Dr.         
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
Principal Investigator: Sven-Axel May         
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie Recruiting
Halle, Germany, 06112
Principal Investigator: Hans-Jörg Meisel, Prof. h.c. Dr. med.         
Neurochirurgische Klinik Recruiting
Hamburg, Germany, 20246
Principal Investigator: Manfred Westphal, Prof. Dr. med         
Katharinenhospital Recruiting
Stuttgart, Germany, 70174
Principal Investigator: Minou Nadji-Ohl         
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Principal Investigator: Garth Cruickshank, Prof         
Addenbrookes NHS Trust Recruiting
Cambridge, United Kingdom, CB2 2QQ
Principal Investigator: Colin Watts, PhD, FRCS         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Stavros Polyzoides   
Principal Investigator: Keyoumars Ashkan, MD         
University College Hospital London Recruiting
London, United Kingdom, NW1 2PG
Contact: Paul Mulholland, MBBS, MSc, PhD    0044 2034 567 890 ext 77699   
Principal Investigator: Paul Mulholland, MBBS, MSc, PhD         
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: June 26, 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 July 01, 2015