Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00022334
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2001-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicity and maximum tolerable dose.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Generation of AFP specific immunity.', 'timeFrame': '3 years'}, {'measure': 'Progression-free survival.', 'timeFrame': '3 years'}, {'measure': 'clinical response in patients with measurable disease.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['localized resectable adult primary liver cancer', 'localized unresectable adult primary liver cancer', 'advanced adult primary liver cancer', 'recurrent adult primary liver cancer', 'adult primary hepatocellular carcinoma'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A\\*0201-positive patients with hepatocellular carcinoma.\n* Determine the safety and toxicity of this regimen in these patients.\n* Determine the immunological effects of this regimen in these patients.\n* Determine the progression-free survival and clinical responses in patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.\n\nCohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.\n\nPatients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HLA-A\\*0201 positive adults over the age of 18.\n* Have HCC with a serum AFP determination \\>30ng/ml.\n* Both male and female patients may be enrolled.\n* Karnofsky Performance Status greater than or equal to 70 percent.\n* No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.\n* No previous evidence of opportunistic infection.\n* Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:\n\n 1. Hemoglobin \\>9.0g/dl\n 2. Platelets \\>50000/mm3\n 3. Absolute Neutrophil Count \\>1,000/mm3\n* Child-Pugh Class A or B for chronic liver disease.\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.\n* Concomitant steroid therapy or chemotherapy, or any of these other treatments \\< 30 days before the first vaccination.\n* Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).\n* Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.\n* HIV-infected patients.\n* Patients with any underlying conditions which would contraindicate therapy with study treatment.\n* Patients with organ allografts.\n* O2 sat \\<91% on room air; dyspnea at rest.'}, 'identificationModule': {'nctId': 'NCT00022334', 'briefTitle': 'Vaccine Therapy in Treating Patients With Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000068806'}, 'secondaryIdInfos': [{'id': 'UCLA-0001026'}, {'id': 'NCI-G01-1997'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'See intervention description.', 'interventionNames': ['Biological: AFP']}], 'interventions': [{'name': 'AFP', 'type': 'BIOLOGICAL', 'otherNames': ['AFP peptide-pulsed autologous DC'], 'description': 'Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'James S. Economou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}