Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221

Description

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Biological: DCVax-L

Specialties

  • Neurology: Neurologic Oncology
  • Oncology: Neurologic Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • DCVax-L
  • Glioblastoma

Study ID

Northwest Biotherapeutics -- 0202EA

Status

Available

Trial ID

NCT02146066

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Northwest Biotherapeutics

Inclusion Criteria

    1. Screen-Fail for protocol 020221 due to either:
  • Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR
  • Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses). 2. Patients must have a KPS rating of ?70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales). 3. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped
  • or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone qd at least 7 days prior to the first immunization . 4. DCVax-L product manufactured and released.

Exclusion Criteria

    1. Active uncontrolled infection, or acute infection requiring antibiotic or antifungal therapy. Antibiotic and antifungal therapy should be completed approximately 7 days prior to the first immunization. 2. Fever ?101.5oF. If considered possibly transient, retesting is allowed. 3. Unstable or severe intercurrent medical conditions. 4. Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm). 020221 Baseline lab results and or local lab results are acceptable.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (26)

Study Location Distance Name Phone Email
Stony Brook University Hospital - Stony Brook, New York 22.8 miles Susan Fiore MS 631-444-9425 susan.fiore@stonybrookmedicine.edu
North Shore University Hospital - Manhasset, New York 37.0 miles Louise Purcell 516-941-1263 lpurcell@nshs.edu
Columbia University Medical Center Neurological Institute of New York - New York, New York 44.8 miles Christina Corpus 212-342-1653 cc2638@cumc.columbia.edu
John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey 47.6 miles Lori Cappello 201-996-5098 LCappello@HackensackUMC.org
Capital Health - Trenton, New Jersey 101.2 miles Cynthia LewisDiaz 609-394-6287 CDiaz@capitalhealth.org
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles Suzanne Frangos RN CNRN 215-285-2885 suzanne.frangos@uphs.upenn.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles Emma Breault 617-667-5984 ebreault@bidmc.harvard.edu
Geisinger Medical Center - Danville, Pennsylvania 176.4 miles Lynne Belles 570-271-6780 lmbelles@geisinger.edu
Aurora Saint Lukes Medical Center - Milwaukee, Wisconsin 339.3 miles Lynda Yanny 414-649-6685 lynda.yanny@aurora.org
Spectrum Health - Grand Rapids, Michigan 648.5 miles Marianne Morrissey 616-391-1129 marianne.morrissey@spectrumhealth.org
Cadence Cancer Center at Warrenville - Warrenville, Illinois 774.6 miles Claudia Fredian 630-352-5261 claudia.fredian@cadencehealth.org
Saint Thomas Research Institute - Nashville, Tennessee 815.8 miles Nancy Grimes RN 615-222-4356 ngrimes@sth.org
Washington University School of Medicine - St. Louis, Missouri 919.8 miles Andrew Wegrzyn 314-747-1825 awegrzyn@dom.wustl.edu
University of Florida - Gainesville, Florida 950.8 miles Whitney McNeal 352-273-7774 Whitney.McNeal@neurosurgery.ufl.edu
John Nasseff Neuroscience Institute Abott Northwestern Hospital - Minneapolis, Minnesota 1,041.4 miles Anna Kistner 612-863-9166 Anna.Kistner@allina.com
Memorial Healthcare System Memorial Cancer Institute - Hollywood, Florida 1,125.0 miles Nithya Sundararaman MA MS MBA CCRP +1-954-265-1846 NSundararaman@mhs.net
University of Arkansas for Medical Sciences - Little Rock, Arkansas 1,131.5 miles Shana Fetters 501-686-8274 FettersShanaM@uams.edu
Saint Lukes Hospital of Kansas City - Kansas City, Missouri 1,137.2 miles Jennifer McIntire 816-932-7985 jmcintire@saint-lukes.org
University of Oklahoma Health Science Center - Oklahoma City, Oklahoma 1,371.2 miles Stephanie McKnight 405-271-8777 Stephanie-Mcknight@ouhsc.edu
University of Colorado Cancer Center - Aurora, Colorado 1,658.2 miles Monica Robischon 720-848-0661 Monica.robischon@ucdenver.edu
Colorado Neurological Institute - Englewood, Colorado 1,666.4 miles Alicia Novak 303-806-7423 anovak@thecni.org
Swedish Neuroscience Institute - Seattle, Washington 2,425.4 miles Nathan Hansen 206-320-3542 Nathan.Hansen@swedish.org
St Joseph Hospital of Orange - Orange, California 2,477.9 miles Martha French 714-734-6200 Martha.French@stjoe.org
University of California Irvine Medical Center - Orange, California 2,477.9 miles Jinah Chung 714-456-8442 jinahec@uci.edu
Hoag Memorial Hospital - Newport Beach, California 2,485.6 miles Robin Bogardus 949-764-4624 alicia.bogardus@hoag.org
UCLA Medical Center - Los Angeles, California 2,499.3 miles Diana Moughon 310-794-4223 dmoughon@mednet.ucla.edu

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