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



Status:Available
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Contact:Marnix Bosch, MBA PhD
Email:marnix@nwbio.com
Phone:240 497 9022

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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

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.

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.

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.
We found this trial at
27
sites
Trenton, New Jersey 08618
Principal Investigator: Arlan Mintz, MD
Phone: 609-394-6287
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David Avigan, MD
Phone: 617-667-5984
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: David Tran, MD
Phone: 352-273-7774
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Shirley Ong, MD
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Phone: 516-941-1263
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Steven Brem, MD
Phone: 215-285-2885
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Aurora, Colorado 80045
Principal Investigator: Kevin Lillehei, MD
Phone: 720-848-0661
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: J. Bradley Elder, MD
Phone: 614-293-8607
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Steven Toms, MD
Phone: 570-271-6780
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Englewood, Colorado
Principal Investigator: Michael Pearlman, MD
Phone: 303-806-7423
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Grand Rapids, Michigan 49503
Principal Investigator: Wendy Sherman, MD
Phone: 616-391-1129
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Samuel Goldlust, MD
Phone: 201-996-5098
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hollywood, Florida 33021
Principal Investigator: Atif Hussein, MD
Phone: +1-954-265-1846
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Darren Lovick, MD
Phone: 816-932-7985
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Linda Liau, MD
Phone: 310-794-4223
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Milwaukee, Wisconsin 53215
Principal Investigator: George Bobustuc, MD
Phone: 414-649-6685
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Minneapolis, Minnesota 55407
Principal Investigator: John Trusheim, MD
Phone: 612-863-9166
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Nashville, Tennessee 37205
Principal Investigator: Steve Abram, MD
Phone: 615-222-4356
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New York, New York 10032
Principal Investigator: Fabio Iwamoto, MD
Phone: 212-342-1653
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Newport Beach, California 92663
Principal Investigator: Christopher Duma, MD
Phone: 949-764-4624
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Oklahoma City, Oklahoma 73104
Principal Investigator: James Battiste, MD
Phone: 405-271-8777
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Orange, California 92868
Principal Investigator: William Loudon, MD
Phone: 714-734-6200
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101 The City Drive South
Orange, California 92868
714-456-7890
Principal Investigator: Daniela Bota, MD
Phone: 714-456-8442
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Seattle, Washington 98122
Principal Investigator: Charles Cobbs, M.D.
Phone: 206-320-3542
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St. Louis, Missouri 63108
Principal Investigator: Jian Campian, MD
Phone: 314-747-1825
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Stony Brook, New York 11794
Principal Investigator: Raphael Davis, M.D.
Phone: 631-444-9425
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Warrenville, Illinois 60555
Principal Investigator: Sean Grimm, MD
Phone: 630-352-5261
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