Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02465268
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2015-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'duane.mitchell@neurosurgery.ufl.edu', 'phone': '352-273-9000', 'title': 'Duane Mitchell, MD, PhD', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.', 'description': 'The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'The active treatment group was arms 1 and 2 combined.\n\nArm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 16, 'seriousNumAtRisk': 36, 'deathsNumAffected': 28, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'The active treatment group was arms 1 and 2 combined.\n\nArm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 11, 'seriousNumAtRisk': 34, 'deathsNumAffected': 31, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 13, 'seriousNumAtRisk': 41, 'deathsNumAffected': 31, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'CD4 Count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophils/granulocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Opportunistic infection associated with >=Grade 2 Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CNS cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood alteration - Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyramidal tract dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other (Specify, appendicitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CNS cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology - Other (Specify, cerebral edema)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nunpulsed PBMC and saline\n\nSaline'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '22.8'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '19.2'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '15.4', 'upperLimit': '30.2'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.77', 'ciUpperLimit': '2.16', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.196', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '0.99', 'ciUpperLimit': '2.70', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first vaccine until the date of death, up to 48 months', 'description': 'Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Survival in Patients receiving vaccine vs placebo.'}, {'type': 'SECONDARY', 'title': 'Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'Plus pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nunpulsed PBMC and saline\n\nSaline'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '11.0'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '10.8'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '14.8'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.354', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.33', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months', 'description': 'Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Progression free survival in patients receiving vaccine vs placebo.'}, {'type': 'SECONDARY', 'title': 'ELISPOT Assay (pp65)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: pp65-shLAMP DC With GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'Arm 2: pp65-flLAMP DC With GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.\n\npp65-flLAMP DC with GM-CSF'}, {'id': 'OG002', 'title': 'Arm 3: Unpulsed PBMC and Saline', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nunpulsed PBMC and saline\n\nSaline'}], 'classes': [{'categories': [{'measurements': [{'value': '126.3', 'spread': '759.9', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '377.5', 'groupId': 'OG001'}, {'value': '-162.7', 'spread': '1075.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.038', 'groupIds': ['OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.038', 'groupIds': ['OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Within patient changes from baseline to vaccine 3.', 'unitOfMeasure': 'spot forming units (SFU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each arm who received at least 3 DC vaccines.'}, {'type': 'SECONDARY', 'title': 'Flow Cytometric Analysis (T Cell)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of T cells within PBMCs.', 'unitOfMeasure': 'percentage of PBMC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who received at least 3 DC vaccines are included.'}, {'type': 'SECONDARY', 'title': 'Cytokine Array Analysis (IFN-g)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '10.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2', 'groupIds': ['OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2', 'groupIds': ['OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who received at least 3 DC vaccines are included in the analysis'}, {'type': 'SECONDARY', 'title': 'ELISPOT Assay (Actin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: pp65-shLAMP DC With GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\npp65-shLAMP DC with GM-CSF\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'Arm 2: pp65-flLAMP DC With GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.\n\npp65-flLAMP DC with GM-CSF'}, {'id': 'OG002', 'title': 'Arm 3: Unpulsed PBMC and Saline', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nunpulsed PBMC and saline\n\nSaline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '26.1', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '9.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6', 'groupIds': ['OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6', 'groupIds': ['OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Within patient changes from baseline to vaccine 3.', 'unitOfMeasure': 'spot forming units (SFU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in each arm who received at least 3 DC vaccines.'}, {'type': 'SECONDARY', 'title': 'Flow Cytometric Analysis (NK Cell)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of NK cells within PBMCs.', 'unitOfMeasure': 'percentage of PBMC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who received at least 3 DC vaccines are included.'}, {'type': 'SECONDARY', 'title': 'Flow Cytometric Analysis (CD4.CD25 T Reg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'OG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs.', 'unitOfMeasure': 'percentage of PBMC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who received at least 3 DC vaccines are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nExperimental Arm 1 pp65-shLAMP DC with GM-CSF and Td\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'FG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.\n\nExperimental Arm 2 pp65-flLAMP DC with GM-CSF and Td\n\nDC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.\n\nTd: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.'}, {'id': 'FG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Not evaluable per protocol criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'did not meet eligibility prior to Cycle #1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Study drug did not pass QA/QC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '175 participants were enrolled (consented) between 8/9/2016 and 10/5/2022.', 'preAssignmentDetails': 'Participants were evaluated for inclusion. 17 were determined not eligible and 4 participants withdrew. 154 participants were randomized with an allocation ratio of 1:1:1 into one of three arms: 1) Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); 2) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); or 3) Arm 3: Unpulsed PBMCs (saline skin prep).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'pp65-shLAMP DC With GM-CSF and Td (Arm 1)', 'description': 'The active treatment group were Arms 1 and 2\n\nArm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}, {'id': 'BG001', 'title': 'pp65-flLAMP DC With GM-CSF and Td (Arm 2)', 'description': 'The active treatment group were Arms 1 and 2\n\nArm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}, {'id': 'BG002', 'title': 'Unpulsed PBMC and Saline (Arm 3)', 'description': 'The control group was Arm 3, Unpulsed PBMCs (saline skin prep)\n\nPrior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'BG000', 'lowerLimit': '32.0', 'upperLimit': '75.0'}, {'value': '56.0', 'groupId': 'BG001', 'lowerLimit': '21.0', 'upperLimit': '79.0'}, {'value': '59.0', 'groupId': 'BG002', 'lowerLimit': '27.0', 'upperLimit': '80.0'}, {'value': '58.0', 'groupId': 'BG003', 'lowerLimit': '21.0', 'upperLimit': '80.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who received at least one DC vaccine were included in the modified intent to treat analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-07', 'size': 1975048, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-31T08:43', 'hasProtocol': True}, {'date': '2021-10-21', 'size': 278466, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-22T10:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2015-05-27', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-19', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)', 'timeFrame': 'From date of first vaccine until the date of death, up to 48 months', 'description': 'Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)', 'timeFrame': 'From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months', 'description': 'Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence.'}, {'measure': 'ELISPOT Assay (pp65)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Within patient changes from baseline to vaccine 3.'}, {'measure': 'Flow Cytometric Analysis (T Cell)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of T cells within PBMCs.'}, {'measure': 'Cytokine Array Analysis (IFN-g)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3.'}, {'measure': 'ELISPOT Assay (Actin)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Within patient changes from baseline to vaccine 3.'}, {'measure': 'Flow Cytometric Analysis (NK Cell)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of NK cells within PBMCs.'}, {'measure': 'Flow Cytometric Analysis (CD4.CD25 T Reg)', 'timeFrame': 'baseline, post-vaccine #3', 'description': 'Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma Multiforme', 'Glioblastoma', 'Malignant Glioma', 'Astrocytoma, Grade IV', 'GBM']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.', 'detailedDescription': "Dendritic cells (DC) are involved in activating, or turning-on, your body's immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual's blood.\n\nIn this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone.\n\nTo see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Abbreviated Inclusion Criteria:\n\nTo be assessed at study enrollment prior to standard of care chemo-radiation therapy:\n\n* Age ≥ 18 years.\n* Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma)\n* The tumor must have a supratentorial component.\n* Must have undergone definitive surgical resection of tumor with less than approximately 3cm x 3cm residual enhancing tumor as product of longest perpendicular planes by MRI.\n* Recovery from the effects of surgery, postoperative infection, and other complications.\n* Diagnostic contrast-enhanced MRI or CT scan of the brain preoperatively and postoperatively.\n* Karnofsky Performance Status of ≥ 70.\n* Signed informed consent.\n* For females of childbearing potential, negative serum pregnancy test.\n* Women of childbearing potential and male participants must be willing to practice adequate contraception throughout the study and for at least 24 weeks after the last dose of study drug.\n\nTo be assessed prior to initiation of adjuvant TMZ:\n\n* Must have completed RT (targeted total dose of 59.4-60.0 Gy over ≤ 7 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for ≤ 49 days) therapy without significant toxicity that persisted over 4 weeks.\n* History \\& physical with neurologic examination prior to initiation of adjuvant TMZ.\n* For patients receiving steroids, daily dose must be ≤ 4 mg.\n* CBC with differential with adequate bone marrow function.\n* Adequate renal function.\n* Adequate hepatic function.\n\nAbbreviated Exclusion Criteria:\n\nTo be verified in order to randomize subject:\n\n* Prior invasive malignancy unless disease free for ≥ 3 years.\n* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.\n* Recurrent or multifocal malignant gliomas.\n* HIV, Hepatitis B, or Hepatitis C seropositive.\n* Known active infection or immunosuppressive disease.\n* Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region.\n* Prior radiotherapy to the head or neck, resulting in overlap of radiation fields.\n* Severe, active co-morbidity.\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period.\n* Pregnant or lactating women.\n* Prior allergic reaction to temozolomide, GM-CSF or Td.\n* Prior history of brachial neuritis or Guillain-Barré syndrome.\n* Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n\nTo be assessed prior to initiation of adjuvant TMZ:\n\n* Did not start radiation therapy and temozolomide within 7 weeks of surgery.\n* Progression of disease as defined by modified RANO criteria.\n* More than 45 days after completion of radiation therapy and temozolomide'}, 'identificationModule': {'nctId': 'NCT02465268', 'acronym': 'ATTAC-II', 'briefTitle': 'Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'ATTAC-II: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma', 'orgStudyIdInfo': {'id': 'IRB201400697-N'}, 'secondaryIdInfos': [{'id': 'R01CA175517', 'link': 'https://reporter.nih.gov/quickSearch/R01CA175517', 'type': 'NIH'}, {'id': 'OCR14127', 'type': 'OTHER', 'domain': 'Universiy of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: pp65-shLAMP DC with GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.', 'interventionNames': ['Biological: pp65-shLAMP DC with GM-CSF', 'Drug: Td']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: pp65-flLAMP DC with GM-CSF and Td', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.', 'interventionNames': ['Drug: Td', 'Biological: pp65-flLAMP DC with GM-CSF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3: unpulsed PBMC and Saline', 'description': 'Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.', 'interventionNames': ['Biological: unpulsed PBMC and saline', 'Drug: Saline']}], 'interventions': [{'name': 'pp65-shLAMP DC with GM-CSF', 'type': 'BIOLOGICAL', 'otherNames': ['pp65-shLAMP mRNA DCs with GM-CSF'], 'armGroupLabels': ['Arm 1: pp65-shLAMP DC with GM-CSF and Td']}, {'name': 'unpulsed PBMC and saline', 'type': 'BIOLOGICAL', 'otherNames': ['Peripheral Blood Mononuclear Cells'], 'armGroupLabels': ['Arm 3: unpulsed PBMC and Saline']}, {'name': 'Td', 'type': 'DRUG', 'otherNames': ['Tetanus and Diphtheria Toxoid'], 'description': 'All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.', 'armGroupLabels': ['Arm 1: pp65-shLAMP DC with GM-CSF and Td', 'Arm 2: pp65-flLAMP DC with GM-CSF and Td']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'armGroupLabels': ['Arm 3: unpulsed PBMC and Saline']}, {'name': 'pp65-flLAMP DC with GM-CSF', 'type': 'BIOLOGICAL', 'otherNames': ['pp65-flLAMP mRNA DCs with GM-CSF'], 'armGroupLabels': ['Arm 2: pp65-flLAMP DC with GM-CSF and Td']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Duane Mitchell, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Florida'}, {'name': 'Maryam Rahman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}