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

Available (expanded access)

Conditions studied: GBM, Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT02146066

Run by

Northwest Biotherapeutics

Last updated by the study team

2016-02-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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