Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
Conditions
Glioblastoma Multiforme - Glioblastoma - GBM - Grade IV Astrocytoma - Glioma - Brain Cancer - Brain Tumor
Conditions: official terms
Astrocytoma - Brain Neoplasms - Glioblastoma - Gliosarcoma
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Dendritic cell immunotherapy
Type: Drug
Overall Status
Recruiting
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. 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)
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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.
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Cathie Robinson - 205-934-2921 - cathierobinson@uabmc.edu
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Recruiting
Contact: Shana Fetters - 501-686-8274 - FettersShanaM@uams.edu
Sutter East Bay Neuroscience Institute-Eden Medical Center
Castro Valley, California, United States
Status: Completed
City of Hope
Duarte, California, United States
Status: Recruiting
Contact: Alexandra Ching - 866-235-3031 - AChing@coh.org
St. Jude Medical Center
Fullerton, California, United States
Status: Recruiting
Contact: Deborah Yoon, RN, SC - 714-446-5364 - Deborah.Yoon@stjoe.org
UCI Medical Center
Irvine, California, United States
Status: Recruiting
Contact: Oliver John Quines - 714-456-6907 - oquines@uci.edu
UCSD Moores Cancer Center
La Jolla, California, United States
Status: Active, not recruiting
Kaiser Permanente - Los Angeles
Los Angeles, California, United States
Status: Recruiting
Contact: Sandra Baker-Bolden - 323-783-5532 - Sandra.T.Baker@kp.org
UCLA
Los Angeles, California, United States
Status: Recruiting
Contact: Emma Billingslea-Yoon, R.N. - 310-267-2621 - ebillingslea@mednet.ucla.edu
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Status: Recruiting
Contact: Robin Ellis - 949-764-5543 - robin.ellis@hoag.org
St. Joseph Hospital of Orange
Orange, California, United States
Status: Recruiting
Contact: Andrew Holman - 714-734-6200 - Andrew.Holman@stjoe.org
Kaiser Permanente - Redwood City
Redwood City, California, United States
Status: Recruiting
Contact: Nancy Mendelssohn - 650-299-4165 - nancy.d.mendelssohn@kp.org
Sutter Institute for Medical Research
Sacramento, California, United States
Status: Recruiting
Contact: Natalie Marlen, CCRC - 916-453-5742 - MarlenN@sutterhealth.org
South Pasadena Cancer Center
South Pasadena, California, United States
Status: Recruiting
Contact: Julie Kilpatrick, RN - 626-256-4673 - Jkilpatrick@coh.org
University of Colorado Cancer Center
Aurora, Colorado, United States
Status: Active, not recruiting
Colorado Neurological Institute
Englewood, Colorado, United States
Status: Recruiting
Contact: Alicia Novak - 303-357-5446 - anovak@thecni.org
Georgetown University Medical Center
Washington, District of Columbia, United States
Status: Completed
University of Florida
Gainesville, Florida, United States
Status: Recruiting
Contact: Whitney McNeal Chapman, RN - 352-273-7774 - Whitney.McNeal@neurosurgery.ufl.edu
Memorial Cancer Institute
Hollywood, Florida, United States
Status: Recruiting
Contact: Nithya Sundararaman, MA, MS, MBA, CCRP - (954) 265 1846 - NSundararaman@mhs.net
Mount Sinai CCOP
Miami Beach, Florida, United States
Status: Recruiting
Contact: Leandro Pisano - 305-674-2625 - Leandro.pisano@msmc.com
Moffitt Cancer Center
Tampa, Florida, United States
Status: Active, not recruiting
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Status: Withdrawn
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Michelle Humphreys - 404-425-7943 - michelle.humphreys@piedmont.org
Rush University Medical Center
Chicago, Illinois, United States
Status: Active, not recruiting
University of Illinois Medical Center
Chicago, Illinois, United States
Status: Withdrawn
Illinois Cancer Care
Peoria, Illinois, United States
Status: Recruiting
Contact: Carrie Margis - 309-243-3621 - cmargis@illinoiscancercare.com
Cadence Cancer Center
Warrenville, Illinois, United States
Status: Active, not recruiting
IU Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Jennifer Funke - 317-278-0328 - jmfunke@iupui.edu
KU Medical Center
Westwood, Kansas, United States
Status: Recruiting
Contact: Ashley Shores - 913-588-1897 - ashores@kumc.edu
Markey Cancer Center/University of Kentucky
Lexington, Kentucky, United States
Status: Recruiting
Contact: Helena Yoder - 312-996-9240 - hyoder@uic.edu
Norton Cancer Institute
Louisville, Kentucky, United States
Status: Recruiting
Contact: Leanne Coleman - Leanne.coleman@nortonhealthcare.org
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Janlyn Murphy - 617-667-1832 - Jmurphy7@bidmc.harvard.edu
Tufts Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Amy Quinkert - 617-636-8589 - aquinkert@tuftsmedicalcenter.org
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Karen Frisch - 734-232-4843 - kfrisch@umich.edu
Henry Ford Hospital
Detroit, Michigan, United States
Status: Recruiting
Contact: Nicole Leon, RN - 313-916-6781 - sleon9@hfhs.org
Spectrum Health
Grand Rapids, Michigan, United States
Status: Recruiting
Contact: Marianne Morrissey - 616-391-1129 - marianne.morrissey@spectrumhealth.org
John Nasseff Neuroscience Institute
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Nilanjana Banerji - 612-262-4837 - Nilanjana.Banerji@allina.com
St. Luke's Hospital
Kansas City, Missouri, United States
Status: Recruiting
Contact: Jennifer McIntire, RN - 816-932-7985 - jmcintire@saint-lukes.org
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Abigail Gwinn - 314-747-4678 - AGwinn@dom.wustl.edu
JFK Brain Tumor Center
Edison, New Jersey, United States
Status: Recruiting
Contact: Charles Porbeni - 732-321-8897 - cporbeni@jfkhealth.org
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Lori Cappello - 201-996-5098 - LCappello@HackensackUMC.org
Overlook Hospital
Summit, New Jersey, United States
Status: Recruiting
Contact: Patricia Eagan, RN - 908-522-5843 - pat.eagan@atlantichealth.org
Capital Health Regional Medical Center
Trenton, New Jersey, United States
Status: Recruiting
Contact: Cynthia Lewis-Diaz - 609-394-6287 - CDiaz@capitalhealth.org
Huntington Hospital
Huntington, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu, MA, CCRC - 516-478-0010 - kprabhu@nspc.com
Long Island Brain Tumor Centre at Neurological Surgery P.C.
Lake Success, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu, MA, CCRP - 631-864-3900 - kprabhu@nspc.com
North Shore Health System
Lake Success, New York, United States
Status: Recruiting
Contact: Louise Purcell - 516-941-1263 - lpurcell@nshs.edu
North Shore University Hospital
Manhasset, New York, United States
Status: Active, not recruiting
Winthrop University Hospital
Mineola, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu - 516-478-0010 - kprabhu@nspc.com
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Christina Corpuz - 212-342-2959 - cc2638@columbia.edu
Mount Sinai Hospital
New York, New York, United States
Status: Recruiting
Contact: Elana Pessin - 212-241-5698 - elana.pessin@mssm.edu
New York University Clinical Cancer Center
New York, New York, United States
Status: Completed
South Nassau Community Hospital
Oceanside, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu, MA, CCRC - 516-478-0010 - kprabhu@nspc.com
University of Rochester Medical Center
Rochester, New York, United States
Status: Recruiting
Contact: Jacqueline Behr - 585-276-3581 - Jacqueline_Behr@URMC.Rochester.edu
Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Kimberly Prabhu, MA, CCRC - 516-478-0010 - kprabhu@nspc.com
Stony Brook University Hospital
Stony Brook, New York, United States
Status: Recruiting
Contact: Susan Fiore, M.S. - 631-444-9425 - susan.fiore@stonybrookmedicine.edu
New York Medical College
Valhalla, New York, United States
Status: Active, not recruiting
Brain and Spine Surgeons of New York and Northern Westchester Hospital
White Plains, New York, United States
Status: Active, not recruiting
University of North Carolina
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Wasi Khan, PhD - 919-843-9499 - Wasi_khan@med.unc.edu
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Jennifer MacLean - 336-713-6915 - jemaclea@wakeforest.edu
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Status: Recruiting
Contact: Suzanne Sifri, RN, BSN - 513-584-0618 - sifrisc@ucmail.uc.edu
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Completed
University Hospitals of Cleveland
Cleveland, Ohio, United States
Status: Recruiting
Contact: Gina Cascone, RN - 216-983-3021 - gina.cascone@uhhospitals.org
Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Contact: Aubrey Hastings - 614-293-8607 - aubrey.hastings@osumc.edu
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Riza Fabreo - 405-271-8777 - riza.fabreo@ouhsc.edu
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Angela Whitmire - 570-214-9603 - awhitmire@geisinger.edu
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Suzanne Frangos, RN, CNRN - 215-285-2885 - suzanne.frangos@uphs.upenn.edu
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Michael Weaver, MD - 215-707-7200 - Michael.Weaver@tuhs.temple.edu
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Michelle Orlando - 215-955-7000 - michelle.orlando@jefferson.edu
Rhode Island Hospital
Providence, Rhode Island, United States
Status: Recruiting
Contact: Wendy Turchetti - 401-444-7740 - wturchetti@lifespan.org
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States
Status: Recruiting
Contact: Michele DeCandio - 843-792-9016 - decandio@musc.edu
St. Thomas Hospital
Nashville, Tennessee, United States
Status: Recruiting
Contact: Nancy Grimes, RN - 615-222-4356 - ngrimes@sth.org
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Katy Lyons, RN BSN CCRC - 800-811-8480 - katie.lyons@vanderbilt.edu
Baylor Research Institute
Dallas, Texas, United States
Status: Recruiting
Contact: Valerie Clark - 214-820-6168 - Valerie.clark@baylorhealth.edu
The Methodist Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Lenis Sosa, BSN, RN, OCN - 713-441-3245 - lsosa@houstonmethodist.org
Yvonne Kew, MD, PhD, Neuro-Oncology Clinic
Houston, Texas, United States
Status: Withdrawn
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Laura Garcia - 210-450-5964 - garciaL@uthscsa.edu
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
Status: Recruiting
Contact: Leila Ponce - 206-342-6926 - leila.ponce@virginiamason.org
Swedish Hospital Neuroscience Research
Seattle, Washington, United States
Status: Recruiting
Contact: Nathan Hansen - 206-320-3542 - Nathan.Hansen@swedish.org
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Lynda Yanny - 414-649-6685 - lynda.yanny@aurora.org
Montreal Neurological Institute, McGill University
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lisa Nezvitsky - +1-514-398-2667 - lisa.nezvitsky@mcgill.ca
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Status: Recruiting
Contact: Anick Champoux - 819-346-1110 Ext. 12811 - achampoux.chus@ssss.gouv.qc.ca
Universitatsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Status: Recruiting
Contact: Andrea Sorokin - +49 (0) 351 458 18157 - Andrea.Sorokin@uniklinikum-dresden.de
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
Chemnitz, Germany
Status: Recruiting
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
Halle, Germany
Status: Recruiting
Neurochirurgische Klinik
Hamburg, Germany
Status: Recruiting
Katharinenhospital
Stuttgart, Germany
Status: Recruiting
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Status: Recruiting
Addenbrookes NHS Trust
Cambridge, United Kingdom
Status: Recruiting
King's College Hospital
London, United Kingdom
Status: Recruiting
Contact: Stavros Polyzoides - Stavros.polyzoidis@nhs.net
University College Hospital London
London, United Kingdom
Status: Recruiting
Contact: Paul Mulholland, MBBS, MSc, PhD - 0044 2034 567 890 - paul.mulholland@nhs.net
Start Date
December 2006
Sponsors
Northwest Biotherapeutics
Source
Northwest Biotherapeutics
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page