GBMDCVax-L EAPNCT02146066
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
A study testing DCVax-L in people with GBM and Glioblastoma Multiforme, run by Northwest Biotherapeutics at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GBM, Glioblastoma Multiforme
- What is being tested?
- DCVax-L
- How many people
- Not given
- Where
- 27 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
- Available
University of Colorado Cancer Center
Aurora, Colorado, 80045
Monica Robischon, 720-848-0661, Monica.robischon@ucdenver.edu
Kevin Lillehei, MD
- Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Emma Breault, 617-667-5984, ebreault@bidmc.harvard.edu
David Avigan, MD
- Available
Ohio State University
Columbus, Ohio, 043210
Aubrey Hastings, 614-293-8607, aubrey.hastings@osumc.edu
J. Bradley Elder, MD
- Available
Geisinger Medical Center
Danville, Pennsylvania, 17822
Lynne Belles, 570-271-6780, lmbelles@geisinger.edu
Steven Toms, MD
- Available
Colorado Neurological Institute
Englewood, Colorado, 80113
Alicia Novak, 303-806-7423, anovak@thecni.org
Michael Pearlman, MD
- Available
University of Florida
Gainesville, Florida, 32611
Whitney McNeal, 352-273-7774, Whitney.McNeal@neurosurgery.ufl.edu
David Tran, MD
- Available
Spectrum Health
Grand Rapids, Michigan, 49503
Marianne Morrissey, 616-391-1129, marianne.morrissey@spectrumhealth.org
Wendy Sherman, MD
- Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Lori Cappello, 201-996-5098, LCappello@HackensackUMC.org
Samuel Goldlust, MD
- Available
Memorial Healthcare System Memorial Cancer Institute
Hollywood, Florida, 33021
Nithya Sundararaman, MA, MS, MBA, CCRP, +1-954-265-1846, NSundararaman@mhs.net
(954) 265 1846
- Available
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Jennifer McIntire, 816-932-7985, jmcintire@saint-lukes.org
Darren Lovick, MD
- Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Shana Fetters, 501-686-8274, FettersShanaM@uams.edu
Shirley Ong, MD
- Available
UCLA Medical Center
Los Angeles, California, 90095
Diana Moughon, 310-794-4223, dmoughon@mednet.ucla.edu
Linda Liau, MD
- Available
North Shore University Hospital
Manhasset, New York, 11030
Louise Purcell, 516-941-1263, lpurcell@nshs.edu
Michael Schulder, MD
- Available
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 23215
Lynda Yanny, 414-649-6685, lynda.yanny@aurora.org
George Bobustuc, MD
- Available
John Nasseff Neuroscience Institute - Abott Northwestern Hospital
Minneapolis, Minnesota, 55407
Anna Kistner, 612-863-9166, Anna.Kistner@allina.com
John Trusheim, MD
- Available
Saint Thomas Research Institute
Nashville, Tennessee, 37205
Nancy Grimes, RN, 615-222-4356, ngrimes@sth.org
Steve Abram, MD
- Available
Columbia University Medical Center Neurological Institute of New York
New York, New York, 10032
Christina Corpus, 212-342-1653, cc2638@cumc.columbia.edu
Fabio Iwamoto, MD
- Available
Hoag Memorial Hospital
Newport Beach, California, 92663
Robin Bogardus, 949-764-4624 ext. 57019, alicia.bogardus@hoag.org
Christopher Duma, MD
- Available
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Stephanie McKnight, 405-271-8777, Stephanie-Mcknight@ouhsc.edu
James Battiste, MD
- Available
St. Joseph Hospital of Orange
Orange, California, 92868
Martha French, 714-734-6200 ext. 40838, Martha.French@stjoe.org
William Loudon, MD
- Available
University of California, Irvine Medical Center
Orange, California, 92868
Jinah Chung, 714-456-8442, jinahec@uci.edu
Daniela Bota, MD
- Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Suzanne Frangos, RN, CNRN, 215-285-2885, suzanne.frangos@uphs.upenn.edu
Dept. of Neurosurgery, (215) 615-5436, Neurosurgery-NCRD@uphs.upenn.edu
- Available
Swedish Neuroscience Institute
Seattle, Washington, 98122
Nathan Hansen, 206-320-3542, Nathan.Hansen@swedish.org
Charles Cobbs, M.D.
- Available
Washington University School of Medicine
St Louis, Missouri, 63110
Andrew Wegrzyn, 314-747-1825, awegrzyn@dom.wustl.edu
Jian Campian, MD
- Available
Stony Brook University Hospital
Stony Brook, New York, 11794
Susan Fiore, M.S., 631-444-9425, susan.fiore@stonybrookmedicine.edu
Raphael Davis, M.D.
- Available
Capital Health
Trenton, New Jersey, 08638
Cynthia Lewis-Diaz, 609-394-6287, CDiaz@capitalhealth.org
Arlan Mintz, MD
- Available
Cadence Cancer Center at Warrenville
Warrenville, Illinois, 60555
Claudia Fredian, 630-352-5261, claudia.fredian@cadencehealth.org
Sean Grimm, MD
About this study
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
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.
Read the 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.
- Conditions
- GBM, Glioblastoma Multiforme
- Being tested
- DCVax-L
- Keywords
- GBM, Brain tumor, glioblastoma, Brain tumor WHO grade IV
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVax-LBiological
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Northwest Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146066
- Sponsor's protocol ID
- 0202EA
- Acronym
- DCVax-L EAP
- Status last verified
- Feb 2016
- First submitted
- 21 May 2014
- Last updated
- 26 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02146066
- Acronym / sponsor ID
- DCVax-L EAP / 0202EA
- Conditions
- GBM, Glioblastoma Multiforme
- Keywords
- GBM, Brain tumor, glioblastoma, Brain tumor WHO grade IV
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Northwest BiotherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Screen-Fail for protocol 020221 due to either:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCVax-LAutologous Dendritic Cells Pulsed with Tumor Lysate Antigen | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCVax-L in people with GBM and Glioblastoma Multiforme, run by Northwest Biotherapeutics at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marnix Bosch, MBA PhD (240 497 9022, marnix@nwbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.