Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
DCVax-L EAP
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
1 other identifier
expanded_access
N/A
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedFebruary 26, 2016
February 1, 2016
May 21, 2014
February 25, 2016
Conditions
Keywords
Interventions
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
St. Joseph Hospital of Orange
Orange, California, 92868, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
University of Florida
Gainesville, Florida, 32611, United States
Memorial Healthcare System Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Cadence Cancer Center at Warrenville
Warrenville, Illinois, 60555, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
John Nasseff Neuroscience Institute - Abott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Capital Health
Trenton, New Jersey, 08638, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Columbia University Medical Center Neurological Institute of New York
New York, New York, 10032, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Ohio State University
Columbus, Ohio, 043210, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 23215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 23, 2014
Last Updated
February 26, 2016
Record last verified: 2016-02