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 2014 by Northwest Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00045968
First received: September 17, 2002
Last updated: June 12, 2014
Last verified: June 2014
  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 2014 (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, 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 Recruiting
Castro Valley, California, United States, 94546
Contact: Lorna Beccaria, RN    510-727-8267    BeccarL@sutterhealth.org   
Principal Investigator: Tyler Kang, MD         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Alexandra Ching    866-235-3031    AChing@coh.org   
Principal Investigator: Jana Portnow, MD         
St. Jude's Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Deborah Yoon, RN, SC    714-446-5364    Deborah.Yoon@stjoe.org   
Principal Investigator: William Loudon, MD         
UCI Medical Center Recruiting
Irvine, California, United States, 92868
Contact: Oliver John Quines    714-456-6244    oquines@uci.edu   
Principal Investigator: Daniela Bota, MD         
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 93093
Contact: Bradley Brown    858-822-5377    bdbrown@ucsd.edu   
Principal Investigator: Santosh Kesari, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Billingslea-Yoon, R.N.    310-267-2621    ebillingslea@mednet.ucla.edu   
Principal Investigator: Linda Liau, MD, PhD         
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         
Sutter Institute for Medical Research Recruiting
Sacramento, California, United States, 95816
Contact: Natalie Marlen, CCRC    916-453-5742    MarlenN@sutterhealth.org   
Principal Investigator: Nora Wu, M.D.         
South Pasadena Cancer Center Recruiting
South Pasadena, California, United States, 91030
Contact: Julie Kilpatrick, RN    626-256-4673    Jkilpatrick@coh.org   
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    Monica.robischon@ucdenver.edu   
Principal Investigator: Kevin Lillehei, MD         
United States, District of Columbia
Georgetown University Medical Center Completed
Washington, District of Columbia, United States, 20057
United States, Florida
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 CCOP Recruiting
Miami Beach, Florida, United States, 33140
Contact: Leandro Pisano    305-674-2625 ext 55629    Leandro.pisano@msmc.com   
Principal Investigator: Jose Lutzky, MD         
Moffit Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Allie Drew    813-745-3229    Allie.drew@moffitt.org   
Principal Investigator: Arnold Etame, MD, PhD         
United States, Georgia
Emory University, Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Kenneth Hill, MD         
United States, Illinois
University of Illinois Medical Center Withdrawn
Chicago, Illinois, United States, 60612
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jeanne Sixta, RN, BSN, OCN    312-942-2388    Jeanne_Sixta@Rush.edu   
Principal Investigator: Robert Aiken, MD         
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
Contact: Carrie Margis    309-243-3621    cmargis@illinoiscancercare.com   
Principal Investigator: Francois Geoffroy, MD         
Central DuPage Cancer Center Recruiting
Warrenville, Illinois, United States
Contact: Claudia Fredian    630-352-5361    Claudia.Fredian@cadencehealth.org   
Principal Investigator: Sean Grimm, MD         
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Funke    317-278-0328    jmfunke@iupui.edu   
Principal Investigator: Stephanie Wagner, MD         
United States, Kansas
KU Medical Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Ashley Shores    913-588-1897    ashores@kumc.edu   
Principal Investigator: Sarah Taylor, M.D.         
United States, Massachusetts
Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
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         
United States, Michigan
University of Michigan, Department of Neurosurgery Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Frisch    734-232-4843    kfrisch@umich.edu   
Contact: Blake Swihart    734-763-9705    blakeswi@umich.edu   
Principal Investigator: Jason Heth, M.D.         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Leon, RN    313-916-6781    sleon9@hfhs.org   
Principal Investigator: Tom Mikkelsen, MD         
United States, Minnesota
John Nasseff Neuroscience Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Nilanjana Banerji    612-262-4837 ext na.Baner    Nilanjana.Banerji@allina.com   
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    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: David Tran, MD, PhD         
United States, New Jersey
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 Active, not recruiting
Summit, New Jersey, United States, 07902
United States, New York
Huntington Hospital Recruiting
Huntington, New York, United States, 11743
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010    kprabhu@nspc.com   
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    kprabhu@nspc.com   
Principal Investigator: Jai Grewal, MD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Kimberly Prabhu, MA, CCRP    516-478-0010    kprabhu@nspc.com   
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Kimberky Prabhu    516-478-0010    kprabhu@nspc.com   
Principal Investigator: Jai Grewal, MD         
New York University Clinical Cancer Center Active, not recruiting
New York, New York, United States, 10016
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christina Corpuz    212-342-2959    cc2638@columbia.edu   
Contact    212-305-9858      
Principal Investigator: Fabio Iwamoto, MD         
South Nassau Community Hospital Recruiting
Oceanside, New York, United States, 11572
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010    kprabhu@nspc.com   
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         
Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11571-9024
Contact: Kimberly Prabhu, MA, CCRC    516-478-0010    kprabhu@nspc.com   
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Susan Fiore, M.S.    631-444-9425    susan.fiore@stonybrookmedicine.edu   
Principal Investigator: Raphael Davis, M.D.         
Brain and Spine Surgeons of New York and Northern Westchester Hospital Recruiting
White Plains, New York, United States, 10604
Contact: Jan Strack, RN    914-517-7982    jstrack@bssny.com   
Principal Investigator: John Abrahams, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Rebecca Lynch    919-843-7112    becky_lynch@med.unc.edu   
Principal Investigator: Matthew Ewend, MD         
United States, Ohio
UC Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Suzanne Sifri, RN, BSN    513-584-0618    sifrisc@ucmail.uc.edu   
Principal Investigator: Rekha Chaudhary, MD         
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Gina Cascone, RN    216-983-3021    gina.cascone@uhhospitals.org   
Principal Investigator: Andrew E. Sloan, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Angela Whitmire    570-214-9603    awhitmire@geisinger.edu   
Principal Investigator: Steven Toms, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Meghan Wakefield    215-503-9110    meghan.wakefield@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         
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Michael Weaver, MD    215-707-7200    Michael.Weaver@tuhs.temple.edu   
Contact: Dept. of Neurosurgery    215-707-7200      
Principal Investigator: Michael Weaver, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Pamela Bakalarski    401-444-9896    pbakalarski@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: Pierre Giglio, MD         
United States, Tennessee
St. Thomas Hospital 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: Valerie Clark    214-820-6168    Valerie.clark@baylorhealth.edu   
Principal Investigator: Karen Fink, MD, PhD         
Yvonne Kew, MD, PhD, Neuro-Oncology Clinic Withdrawn
Houston, Texas, United States, 77030
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Kimbra Harris    713-441-3834    ksharris@tmhs.org   
Principal Investigator: Pamela New, MD         
Cancer Therapy & Research at University of Texas Health Science Center San Antonio ( UTHSCA) Recruiting
San Antonio, Texas, United States, 78229
Contact: Cherie Noles    210-450-5964    nolesc@uthscsa.edu   
Principal Investigator: Andrew Brenner, MD         
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
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.         
Germany
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Saxony, Germany
Contact: Andrea Sorokin    +49 (0) 351 458 18157    Andrea.Sorokin@uniklinikum-dresden.de   
Principal Investigator: Gabriele Schackert, Prof, Dr.         
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Stavros Polyzoides       Stavros.polyzoidis@nhs.net   
Principal Investigator: Keyoumars Ashkan, MD         
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: June 12, 2014
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
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
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

ClinicalTrials.gov processed this record on July 28, 2014