Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-13 @ 11:12 PM
Study NCT ID:
NCT00890032
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2009-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and safety', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Humoral and cellular immune responses', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult giant cell glioblastoma', 'adult glioblastoma', 'adult gliosarcoma', 'adult astrocytoma', 'recurrent adult brain tumor'], 'conditions': ['Recurrent Central Nervous System Neoplasm']}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme.\n\nSecondary\n\n* To assess humoral and cellular immune responses to vaccination.\n* To compare the proportion of vaccinated patients alive at 6 months from the time of surgery for recurrent tumor with matched historical cohorts.\n\nOUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the third vaccination and then at least every 3 months as needed for generation of additional DCs.\n\nPatients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3 weeks and then once monthly in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years of age\n* First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM\n* No known contraindications to receiving Avastin\n* Karnofsky Performance Status (KPS) of \\> 70%\n* Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry\n\nExclusion Criteria:\n\n* Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)\n* Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment\n* Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study\n* Active infection requiring treatment or an unexplained febrile (\\> 101.5 degrees F) illness\n* Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C\n* Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 \\< 50%) disease, uncontrolled diabetes mellitus\n* Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery\n* Prior inguinal lymph node dissection\n\nAvastin-Specific Exclusion Criteria\n\nSubjects meeting any of the following criteria are ineligible for study entry:\n\n* Inadequately controlled hypertension (defined as systolic blood pressure \\>150 mmHg and/or diastolic blood pressure \\> 100 mmHg)\n* Prior history of hypertensive crisis or hypertensive encephalopathy\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment\n* History of stroke or transient ischemic attack within 6 months prior to enrollment\n* Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)\n* History of hemoptysis (\\> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment\n* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment\n* Serious, non-healing wound, active ulcer or untreated bone fracture\n* Proteinuria as defined by \\> +1 on urinalysis dipstick\n* Known hypersensitivity to any component of Avastin\n* Pregnant (positive pregnancy test) or lactation'}, 'identificationModule': {'nctId': 'NCT00890032', 'briefTitle': 'Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial', 'orgStudyIdInfo': {'id': 'Pro00006677'}, 'secondaryIdInfos': [{'id': 'R01CA135272', 'link': 'https://reporter.nih.gov/quickSearch/R01CA135272', 'type': 'NIH'}, {'id': 'P30CA014236', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014236', 'type': 'NIH'}, {'id': 'CDR0000630701', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTSC mRNA-loaded DCs', 'description': 'BTSC mRNA-loaded DCs administered intradermally weekly for first 3 vaccines, then monthly until progression or withdrawal.', 'interventionNames': ['Biological: BTSC mRNA-loaded DCs']}], 'interventions': [{'name': 'BTSC mRNA-loaded DCs', 'type': 'BIOLOGICAL', 'description': 'An escalating total dose of BTSC mRNA-loaded DCs (2x10\\^6, 5x10\\^6, and 2x10\\^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).', 'armGroupLabels': ['BTSC mRNA-loaded DCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Gordana Vlahovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Sampson', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurosurgery', 'investigatorFullName': 'John Sampson', 'investigatorAffiliation': 'Duke University'}}}}