Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-05 @ 6:53 PM
Study NCT ID:
NCT02146066
Status:
AVAILABLE
Last Update Posted:
2016-02-26
First Post:
2014-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'AVAILABLE', 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['GBM', 'Brain tumor', 'glioblastoma', 'Brain tumor WHO grade IV'], 'conditions': ['GBM', 'Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nTreatment Schedule:\n\nOpen 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Screen-Fail for protocol 020221 due to either:\n\n * Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR\n * Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses).\n2. Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales).\n3. 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 .\n4. DCVax-L product manufactured and released.\n\nExclusion Criteria:\n\n1. 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.\n2. Fever ≥101.5oF. If considered possibly transient, retesting is allowed.\n3. Unstable or severe intercurrent medical conditions.\n4. 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.'}, 'identificationModule': {'nctId': 'NCT02146066', 'acronym': 'DCVax-L EAP', 'briefTitle': 'Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221', 'organization': {'class': 'INDUSTRY', 'fullName': 'Northwest Biotherapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '0202EA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DCVax-L', 'type': 'BIOLOGICAL', 'description': 'Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Shana Fetters', 'role': 'CONTACT', 'email': 'FettersShanaM@uams.edu', 'phone': '501-686-8274'}, {'name': 'Shirley Ong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Diana Moughon', 'role': 'CONTACT', 'email': 'dmoughon@mednet.ucla.edu', 'phone': '310-794-4223'}, {'name': 'Linda Liau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Robin Bogardus', 'role': 'CONTACT', 'email': 'alicia.bogardus@hoag.org', 'phone': '949-764-4624', 'phoneExt': '57019'}, {'name': 'Christopher Duma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Memorial Hospital', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Martha French', 'role': 'CONTACT', 'email': 'Martha.French@stjoe.org', 'phone': '714-734-6200', 'phoneExt': '40838'}, {'name': 'William Loudon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Joseph Hospital of Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jinah Chung', 'role': 'CONTACT', 'email': 'jinahec@uci.edu', 'phone': '714-456-8442'}, {'name': 'Daniela Bota, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Monica Robischon', 'role': 'CONTACT', 'email': 'Monica.robischon@ucdenver.edu', 'phone': '720-848-0661'}, {'name': 'Kevin Lillehei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Alicia Novak', 'role': 'CONTACT', 'email': 'anovak@thecni.org', 'phone': '303-806-7423'}, {'name': 'Michael Pearlman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Whitney McNeal', 'role': 'CONTACT', 'email': 'Whitney.McNeal@neurosurgery.ufl.edu', 'phone': '352-273-7774'}, {'name': 'David Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Nithya Sundararaman, MA, MS, MBA, CCRP', 'role': 'CONTACT', 'email': 'NSundararaman@mhs.net', 'phone': '+1-954-265-1846'}, {'role': 'CONTACT', 'phone': '(954) 265 1846'}, {'name': 'Atif Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Healthcare System Memorial Cancer Institute', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '60555', 'city': 'Warrenville', 'state': 'Illinois', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Claudia Fredian', 'role': 'CONTACT', 'email': 'claudia.fredian@cadencehealth.org', 'phone': '630-352-5261'}, {'name': 'Sean Grimm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cadence Cancer Center at Warrenville', 'geoPoint': {'lat': 41.81781, 'lon': -88.1734}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Emma Breault', 'role': 'CONTACT', 'email': 'ebreault@bidmc.harvard.edu', 'phone': '617-667-5984'}, {'name': 'David Avigan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Marianne Morrissey', 'role': 'CONTACT', 'email': 'marianne.morrissey@spectrumhealth.org', 'phone': '616-391-1129'}, {'name': 'Wendy Sherman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Anna Kistner', 'role': 'CONTACT', 'email': 'Anna.Kistner@allina.com', 'phone': '612-863-9166'}, {'name': 'John Trusheim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Nasseff Neuroscience Institute - Abott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jennifer McIntire', 'role': 'CONTACT', 'email': 'jmcintire@saint-lukes.org', 'phone': '816-932-7985'}, {'name': 'Darren Lovick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Andrew Wegrzyn', 'role': 'CONTACT', 'email': 'awegrzyn@dom.wustl.edu', 'phone': '314-747-1825'}, {'name': 'Jian Campian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Lori Cappello', 'role': 'CONTACT', 'email': 'LCappello@HackensackUMC.org', 'phone': '201-996-5098'}, {'name': 'Samuel Goldlust, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08638', 'city': 'Trenton', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Cynthia Lewis-Diaz', 'role': 'CONTACT', 'email': 'CDiaz@capitalhealth.org', 'phone': '609-394-6287'}, {'name': 'Arlan Mintz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Capital Health', 'geoPoint': {'lat': 40.21705, 'lon': 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'email': 'susan.fiore@stonybrookmedicine.edu', 'phone': '631-444-9425'}, {'name': 'Raphael Davis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '043210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Aubrey Hastings', 'role': 'CONTACT', 'email': 'aubrey.hastings@osumc.edu', 'phone': '614-293-8607'}, {'name': 'J. Bradley Elder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Stephanie McKnight', 'role': 'CONTACT', 'email': 'Stephanie-Mcknight@ouhsc.edu', 'phone': '405-271-8777'}, {'name': 'James Battiste, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Lynne Belles', 'role': 'CONTACT', 'email': 'lmbelles@geisinger.edu', 'phone': '570-271-6780'}, {'name': 'Steven Toms, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Suzanne Frangos, RN, CNRN', 'role': 'CONTACT', 'email': 'suzanne.frangos@uphs.upenn.edu', 'phone': '215-285-2885'}, {'name': 'Dept. of Neurosurgery', 'role': 'CONTACT', 'email': 'Neurosurgery-NCRD@uphs.upenn.edu', 'phone': '(215) 615-5436'}, {'name': 'Steven Brem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Nancy Grimes, RN', 'role': 'CONTACT', 'email': 'ngrimes@sth.org', 'phone': '615-222-4356'}, {'name': 'Steve Abram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Thomas Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Nathan Hansen', 'role': 'CONTACT', 'email': 'Nathan.Hansen@swedish.org', 'phone': '206-320-3542'}, {'name': 'Charles Cobbs, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Swedish Neuroscience Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '23215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Lynda Yanny', 'role': 'CONTACT', 'email': 'lynda.yanny@aurora.org', 'phone': '414-649-6685'}, {'name': 'George Bobustuc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Marnix Bosch, MBA PhD', 'role': 'CONTACT', 'email': 'marnix@nwbio.com', 'phone': '240 497 9022'}, {'name': 'Meghan Swardstrom', 'role': 'CONTACT', 'email': 'mswardstrom@nwbio.com', 'phone': '425 492 6036'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwest Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}