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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Northwest Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00045968
First received: September 17, 2002
Last updated: August 31, 2015
Last verified: August 2015
  Purpose

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
Glioblastoma
GBM
Grade IV Astrocytoma
Glioma
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00045968

Contacts
Contact: Marnix L Bosch, MBA, PhD 240-497-9022 marnix@nwbio.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Cathie Robinson    205-934-2921    cathierobinson@uabmc.edu   
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    FettersShanaM@uams.edu   
Principal Investigator: Shirley Ong, MD         
United States, California
Sutter East Bay Neuroscience Institute-Eden Medical Center Completed
Castro Valley, California, United States, 94546
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Julie Kilpatrick    626-256-4673 ext 61457    jkilpatrick@coh.org   
Principal Investigator: Jana Portnow, MD         
UCSD Moores Cancer Center Completed
La Jolla, California, United States, 93093
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Billingslea-Yoon, RN    310-267-2621    ebillingslea@mednet.ucla.edu   
Principal Investigator: Linda Liau, MD, PhD         
Kaiser Permanente - Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sandra Baker-Bolden    323-783-5532    Sandra.T.Baker@kp.org   
Principal Investigator: Richard M. Green, MD         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Robin Ellis    949-764-5543    robin.ellis@hoag.org   
Principal Investigator: Christopher Duma, MD         
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Andrew Holman    714-734-6200 ext 40842    Andrew.Holman@stjoe.org   
Principal Investigator: William Loudon, MD         
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Oliver John Quines    714-456-6907    oquines@uci.edu   
Principal Investigator: Daniela Bota, MD         
Kaiser Permanente - Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Nancy Mendelssohn    650-299-4165    nancy.d.mendelssohn@kp.org   
Principal Investigator: Victor Tse, MD         
Sutter Institute for Medical Research Recruiting
Sacramento, California, United States, 95816
Contact: Natalie Marlen, CCRC    916-453-5742    MarlenN@sutterhealth.org   
Principal Investigator: Stacy D'Andre, M.D.         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Monica Robischon    720-848-0661    Monica.robischon@ucdenver.edu   
Principal Investigator: Kevin Lillehei, MD         
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Alicia Novak    303-357-5446    anovak@thecni.org   
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 Chapman McNeal, RN    352-273-7774    Whitney.McNeal@neurosurgery.ufl.edu   
Principal Investigator: David Tran, MD         
Memorial Cancer Institute Recruiting
Hollywood, Florida, United States, 33021
Contact: Nithya Sundararaman, MA, MS, MBA, CCRP    (954) 265 1846    NSundararaman@mhs.net   
Contact    (954) 265 1846      
Principal Investigator: Atif Hussein, MD         
Mount Sinai Community Clinical Oncology Program Recruiting
Miami Beach, Florida, United States, 33140
Contact: Leandro Pisano    305-674-2625 ext 55629    Leandro.pisano@msmc.com   
Principal Investigator: Jose Lutzky, MD         
Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory University, Winship Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30322
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Michelle Humphreys    404-425-7943    michelle.humphreys@piedmont.org   
Principal Investigator: Erin Dunbar, MD         
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: Jessica Jones    309-243-3615    jjones@illinoiscancercare.com   
Principal Investigator: Francois Geoffroy, MD         
Cadence Cancer Center Active, not recruiting
Warrenville, Illinois, United States, 60555
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Funke    317-278-0328    jmfunke@iupui.edu   
Principal Investigator: Edward Dropcho, MD         
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Ashley Shores    913-588-1897    ashores@kumc.edu   
Principal Investigator: Sarah Taylor, MD         
United States, Kentucky
Markey Cancer Center/University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: April Howard    859-257-2208    april.howard@uky.edu   
Principal Investigator: John Villano, MD         
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Leanne Coleman       Leanne.coleman@nortonhealthcare.org   
Principal Investigator: Renato LaRocca, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Janlyn Murphy    617-667-1832    Jmurphy7@bidmc.harvard.edu   
Principal Investigator: David Avigan, MD         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amy Quinkert    617-636-8589    aquinkert@tuftsmedicalcenter.org   
Principal Investigator: Julian Wu, MD         
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nicholas Schiavo    734-763-5492    nschiavo@med.umich.edu   
Principal Investigator: Jason Heth, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Emily A. Krozek    313-916-1736    ekrozek1@hfhs.org   
Principal Investigator: Tom Mikkelsen, MD         
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Todd Vitaz    616-267-7900    todd.vitaz@spectrumhealth.org   
Principal Investigator: Wendy Sherman, MD         
United States, Minnesota
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Nilanjana Banerji    612-863-3042    Nilanjana.Banerji@allina.com   
Principal Investigator: John Trusheim, MD         
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jennifer McIntire, RN    816-932-7985    jmcintire@saint-lukes.org   
Principal Investigator: Darren Lovick, MD         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Abigail Gwinn    314-747-4678    AGwinn@dom.wustl.edu   
Principal Investigator: Jian Campian, MD         
United States, New Jersey
The Brain Tumor Center at JFK Medical Center Recruiting
Edison, New Jersey, United States, 08818
Contact: Charles Porbeni    732-321-8897    cporbeni@jfkhealth.org   
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    LCappello@HackensackUMC.org   
Principal Investigator: Samuel Goldlust, MD         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Patricia Eagan, RN    908-522-5843    pat.eagan@atlantichealth.org   
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    CDiaz@capitalhealth.org   
Principal Investigator: Arlan Mintz, MD         
United States, New York
Long Island Brain Tumor Center at Neurological Surgery, P.C. Recruiting
Lake Success, New York, United States, 11042
Contact: Kimberly Prabhu, MA, CCRP    631-864-3900    kprabhu@nspc.com   
Principal Investigator: J. Paul Duic, MD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Louise Purcell    516-941-1263    lpurcell@nshs.edu   
Principal Investigator: Michael Schulder, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Maggie Cochran    212-305-6679    mc3872@cumc.columbia.edu   
Principal Investigator: Fabio M. Iwamoto, MD         
New York University Clinical Cancer Center Completed
New York, New York, United States, 10016
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029-6574
Contact: Elana Pessin    212-241-5698    elana.pessin@mssm.edu   
Principal Investigator: Adilia Hormigo, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jacqueline Behr    585-276-3581    Jacqueline_Behr@URMC.Rochester.edu   
Principal Investigator: Kevin Walter, MD         
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794
Contact: Susan Fiore, M.S.    631-444-9425    susan.fiore@stonybrookmedicine.edu   
Principal Investigator: Raphael Davis, MD         
New York Medical College Withdrawn
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, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Stephanie Shapiro    919-966-4432    stephanie_shapiro@med.unc.edu   
Principal Investigator: Matthew Ewend, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jennifer MacLean    336-713-6915    jemaclea@wakehealth.edu   
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    sifrisc@ucmail.uc.edu   
Principal Investigator: Richard Curry, MD         
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
University Hospitals Seidman Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Gina Cascone, RN    216-983-3021    gina.cascone@uhhospitals.org   
Principal Investigator: Andrew E. Sloan, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Aubrey Hastings    614-293-8607    aubrey.hastings@osumc.edu   
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: Stephanie McKnight    405-271-8777    Stephanie-Mcknight@ouhsc.edu   
Principal Investigator: James Battiste, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Lynne Belles    570-271-6780    lmbelles@geisinger.edu   
Principal Investigator: Steven Toms, MD         
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Carol Von Hofen    215-707-4071    carol.vonhofen@tuhs.temple.edu   
Contact: Kathleen Hatala    215-707-4171    Kathleen.hatala@tuhs.temple.edu   
Principal Investigator: Michael Weaver, MD         
Jefferson Hospital for Neuroscience Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michelle Orlando    215-955-7000    michelle.orlando@jefferson.edu   
Principal Investigator: Lyndon Kim, M.D.         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Suzanne Frangos, RN, CNRN    215-285-2885    suzanne.frangos@uphs.upenn.edu   
Contact: Dept. of Neurosurgery    (215) 615-5436    Neurosurgery-NCRD@uphs.upenn.edu   
Principal Investigator: Steven Brem, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Wendy Turchetti    401-444-7740    wturchetti@lifespan.org   
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    decandio@musc.edu   
Principal Investigator: Scott Lindhorst, MD         
United States, Tennessee
Saint Thomas Research Institute Recruiting
Nashville, Tennessee, United States, 37205
Contact: Nancy Grimes, RN    615-222-4356    ngrimes@sth.org   
Principal Investigator: Steve Abram, MD         
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Katy Lyons, RN BSN CCRC    800-811-8480    katie.lyons@vanderbilt.edu   
Principal Investigator: Reid Thompson, MD         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Stephanie Peschka    214-818-8196    stephanie.peschka@baylorhealth.edu   
Principal Investigator: Karen Fink, MD, PhD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lenis Sosa, BSN, RN, OCN    713-441-3245    lsosa@houstonmethodist.org   
Principal Investigator: David Baskin, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Maynk Rao    713-704-2639    mailto:mayank.rao@uth.tmc.edu   
Principal Investigator: Jay-Jiguang Zhu, 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: Cherie Noles    210-450-5964    nolesc@uthscsa.edu   
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    leila.ponce@virginiamason.org   
Principal Investigator: Lynne Taylor, MD         
Swedish Hospital Neuroscience Research Recruiting
Seattle, Washington, United States, 98122
Contact: Nathan Hansen    206-320-3542    Nathan.Hansen@swedish.org   
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    lynda.yanny@aurora.org   
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    lisa.nezvitsky@mcgill.ca   
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    achampoux.chus@ssss.gouv.qc.ca   
Principal Investigator: David Mathieu, M.D., F.R.C.S.(C)         
Germany
Universitätsklinikum Heidelberg Neurochirurgische Klinik Active, not recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Katharinenhospital Recruiting
Stuttgart, Baden-Württemberg, Germany, 70174
Contact: Minou Nadji-Ohl    +49 711 278 33716    m.nadji-ohl@klinikum-stuttgart.de   
Principal Investigator: Minou Nadji-Ohl         
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie Active, not recruiting
Frankfurt, Hesse, Germany, 60528
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie Recruiting
Halle, Saxony-Anhalt, Germany, 06112
Contact: Hans-Jörg Meisel, Prof. h.c. Dr. med.    +49 3451327404    meisel@bergmannstrost.com   
Principal Investigator: Hans-Jörg Meisel, Prof. h.c. Dr. med.         
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Saxony, Germany, 09116
Contact: Sven-Axel May, Dr. med.    +49 37133333210    s-a.may@skc.de   
Principal Investigator: Sven-Axel May, Dr. med.         
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact: Gabriele Schackert, Prof, Dr.    +49 3514582883    Gabriele.Schackert@uniklinikum-dresden.de   
Principal Investigator: Gabriele Schackert, Prof, Dr.         
Neurochirurgische Klinik Recruiting
Hamburg, Germany, 20246
Contact: Manfred Westphal, Prof. Dr. med    +49 40741053750    westphal@uke.uni-hamburg.de   
Principal Investigator: Manfred Westphal, Prof. Dr. med         
United Kingdom
Addenbrookes NHS Trust Recruiting
Cambridge, Cambridgeshire, East Anglia, United Kingdom, CB2 2QQ
Contact: Colin Watts, PhD, FRCS    +44 1223336946    cw209@cam.ac.uk   
Principal Investigator: Colin Watts, PhD, FRCS         
Kings College Hosital NHS Foundation Trust Recruiting
London, Greater London, United Kingdom, SE5 9RS
Contact: Keyoumars Ashkan, MD    +44 2032993285    k.ashkan@nhs.net   
Principal Investigator: Keyoumars Ashkan, MD         
University College Hospital London Recruiting
London, Greater London, United Kingdom, WC1E 6BT
Contact: Paul Mulholland, MBBS, MSc, PhD, MRCP    +44 2034477699 ext 77699    paul.mulholland@nhs.net   
Principal Investigator: Paul Mulholland, MBBS, MSc, PhD, MRCP         
University Hospital of Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, N15 2WB
Contact: Garth Cruickshank, Prof    +44 1213716865    garth.cruickshank@uhb.nhs.uk   
Principal Investigator: Garth Cruickshank, Prof         
Sponsors and Collaborators
Northwest Biotherapeutics
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT00045968     History of Changes
Other Study ID Numbers: 020221
Study First Received: September 17, 2002
Last Updated: August 31, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwest Biotherapeutics:
oncology
neurology
glioma
brain tumor
brain cancer
glioblastoma multiforme
glioblastoma
newly diagnosed glioblastoma
immunotherapy
dendritic cells
immune therapy
GBM
Brain cancer, primary
tumor vaccine
grade IV astrocytoma
DCVax
Grade IV brain cancer

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Glioblastoma
Gliosarcoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
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

ClinicalTrials.gov processed this record on August 31, 2015