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

Primary Purpose

GBM, Glioblastoma Multiforme

Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
DCVax-L
Sponsored by
Northwest Biotherapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for GBM focused on measuring GBM, Brain tumor, glioblastoma, Brain tumor WHO grade IV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • UCLA Medical Center
  • Hoag Memorial Hospital
  • St. Joseph Hospital of Orange
  • University of California, Irvine Medical Center
  • University of Colorado Cancer Center
  • Colorado Neurological Institute
  • University of Florida
  • Memorial Healthcare System Memorial Cancer Institute
  • Cadence Cancer Center at Warrenville
  • Beth Israel Deaconess Medical Center
  • Spectrum Health
  • John Nasseff Neuroscience Institute - Abott Northwestern Hospital
  • Saint Luke's Hospital of Kansas City
  • Washington University School of Medicine
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Capital Health
  • North Shore University Hospital
  • Columbia University Medical Center Neurological Institute of New York
  • Stony Brook University Hospital
  • Ohio State University
  • University of Oklahoma Health Science Center
  • Geisinger Medical Center
  • Hospital of the University of Pennsylvania
  • Saint Thomas Research Institute
  • Swedish Neuroscience Institute
  • Aurora Saint Luke's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 21, 2014
Last Updated
February 25, 2016
Sponsor
Northwest Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02146066
Brief Title
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
Acronym
DCVax-L EAP
Official Title
An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221
Study Type
Expanded Access

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwest Biotherapeutics

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Patients who are being screened under protocol 020221 who are not eligible for enrollment due to a) evidence of disease progression or pseudo-progression post chemo-radiation or b) insufficient (<5 doses) vaccine manufactured, and for whom the DCVax-L treatment was manufactured and released are eligible for this study. Treatment Schedule: Open label vaccine injections will be give per the associated 020221 protocol. Injections will be given at days 0, 10, 20, and at months 2, 4, 8, 12, 18, 24 and 30. There are no therapeutic restrictions, but guidelines for drug administration are recommended as per the 020221 protocol. Data collected includes vaccine administration information, and any vaccine related adverse event. Patient MRIs will be collected centrally for future review. Patients will be followed for disease progression and survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GBM, Glioblastoma Multiforme
Keywords
GBM, Brain tumor, glioblastoma, Brain tumor WHO grade IV

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
DCVax-L
Intervention Description
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria: 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). Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales). 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 . DCVax-L product manufactured and released. Exclusion Criteria: 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. Fever ≥101.5oF. If considered possibly transient, retesting is allowed. Unstable or severe intercurrent medical conditions. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marnix Bosch, MBA PhD
Phone
240 497 9022
Email
marnix@nwbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Swardstrom
Phone
425 492 6036
Email
mswardstrom@nwbio.com
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shana Fetters
Phone
501-686-8274
Email
FettersShanaM@uams.edu
First Name & Middle Initial & Last Name & Degree
Shirley Ong, MD
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Moughon
Phone
310-794-4223
Email
dmoughon@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Linda Liau, MD
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Bogardus
Phone
949-764-4624
Ext
57019
Email
alicia.bogardus@hoag.org
First Name & Middle Initial & Last Name & Degree
Christopher Duma, MD
Facility Name
St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha French
Phone
714-734-6200
Ext
40838
Email
Martha.French@stjoe.org
First Name & Middle Initial & Last Name & Degree
William Loudon, MD
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinah Chung
Phone
714-456-8442
Email
jinahec@uci.edu
First Name & Middle Initial & Last Name & Degree
Daniela Bota, MD
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Robischon
Phone
720-848-0661
Email
Monica.robischon@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Kevin Lillehei, MD
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Novak
Phone
303-806-7423
Email
anovak@thecni.org
First Name & Middle Initial & Last Name & Degree
Michael Pearlman, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney McNeal
Phone
352-273-7774
Email
Whitney.McNeal@neurosurgery.ufl.edu
First Name & Middle Initial & Last Name & Degree
David Tran, MD
Facility Name
Memorial Healthcare System Memorial Cancer Institute
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nithya Sundararaman, MA, MS, MBA, CCRP
Phone
+1-954-265-1846
Email
NSundararaman@mhs.net
Phone
(954) 265 1846
First Name & Middle Initial & Last Name & Degree
Atif Hussein, MD
Facility Name
Cadence Cancer Center at Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Fredian
Phone
630-352-5261
Email
claudia.fredian@cadencehealth.org
First Name & Middle Initial & Last Name & Degree
Sean Grimm, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Breault
Phone
617-667-5984
Email
ebreault@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
David Avigan, MD
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Morrissey
Phone
616-391-1129
Email
marianne.morrissey@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Wendy Sherman, MD
Facility Name
John Nasseff Neuroscience Institute - Abott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Kistner
Phone
612-863-9166
Email
Anna.Kistner@allina.com
First Name & Middle Initial & Last Name & Degree
John Trusheim, MD
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McIntire
Phone
816-932-7985
Email
jmcintire@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Darren Lovick, MD
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wegrzyn
Phone
314-747-1825
Email
awegrzyn@dom.wustl.edu
First Name & Middle Initial & Last Name & Degree
Jian Campian, MD
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Cappello
Phone
201-996-5098
Email
LCappello@HackensackUMC.org
First Name & Middle Initial & Last Name & Degree
Samuel Goldlust, MD
Facility Name
Capital Health
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08638
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Lewis-Diaz
Phone
609-394-6287
Email
CDiaz@capitalhealth.org
First Name & Middle Initial & Last Name & Degree
Arlan Mintz, MD
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Purcell
Phone
516-941-1263
Email
lpurcell@nshs.edu
First Name & Middle Initial & Last Name & Degree
Michael Schulder, MD
Facility Name
Columbia University Medical Center Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Corpus
Phone
212-342-1653
Email
cc2638@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Fabio Iwamoto, MD
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Fiore, M.S.
Phone
631-444-9425
Email
susan.fiore@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Raphael Davis, M.D.
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
043210
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aubrey Hastings
Phone
614-293-8607
Email
aubrey.hastings@osumc.edu
First Name & Middle Initial & Last Name & Degree
J. Bradley Elder, MD
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie McKnight
Phone
405-271-8777
Email
Stephanie-Mcknight@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
James Battiste, MD
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynne Belles
Phone
570-271-6780
Email
lmbelles@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Steven Toms, MD
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Frangos, RN, CNRN
Phone
215-285-2885
Email
suzanne.frangos@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Dept. of Neurosurgery
Phone
(215) 615-5436
Email
Neurosurgery-NCRD@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Steven Brem, MD
Facility Name
Saint Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Grimes, RN
Phone
615-222-4356
Email
ngrimes@sth.org
First Name & Middle Initial & Last Name & Degree
Steve Abram, MD
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Hansen
Phone
206-320-3542
Email
Nathan.Hansen@swedish.org
First Name & Middle Initial & Last Name & Degree
Charles Cobbs, M.D.
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
23215
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Yanny
Phone
414-649-6685
Email
lynda.yanny@aurora.org
First Name & Middle Initial & Last Name & Degree
George Bobustuc, MD

12. IPD Sharing Statement

Learn more about this trial

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

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