Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
NCT ID: NCT02146066
Last Updated: 2016-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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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.
Conditions
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Interventions
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DCVax-L
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Northwest Biotherapeutics
INDUSTRY
Responsible Party
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Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
St. Joseph Hospital of Orange
Orange, California, United States
University of California, Irvine Medical Center
Orange, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
Memorial Healthcare System Memorial Cancer Institute
Hollywood, Florida, United States
Cadence Cancer Center at Warrenville
Warrenville, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
John Nasseff Neuroscience Institute - Abott Northwestern Hospital
Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Capital Health
Trenton, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Columbia University Medical Center Neurological Institute of New York
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Michael Schulder, MD
Role: backup
Other Identifiers
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0202EA
Identifier Type: -
Identifier Source: org_study_id
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