Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT00101166
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2005-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C094534', 'term': 'polyvalent melanoma cell vaccine'}, {'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sophie.dessureault@moffitt.org', 'phone': '813-745-1965', 'title': 'Dr. Sophie Dessureault', 'organization': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to the heterogeneity of the patient population, results were mainly descriptive in nature.'}}, 'adverseEventsModule': {'timeFrame': 'Average of 14 months. Every 4 weeks throughout the 4 month treatment phase and every 3 months thereafter.', 'description': 'As in our Phase I study, there were no recorded systemic toxicities associated with the vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.', 'otherNumAtRisk': 28, 'otherNumAffected': 10, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain - Cardiac - Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE-3'}, {'term': 'Transient localized erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE-3'}, {'term': 'mild pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE-3'}, {'term': 'Localized depigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE-3'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE-3'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Average of 14 months', 'description': 'Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 participants who were vaccinated on this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Average of 14 months', 'description': 'Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 participants who were vaccinated on this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stable Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Average of 14 months', 'description': 'Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 participants who were vaccinated on this study.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP) in Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of 14 months', 'description': 'Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 participants who were vaccinated on this study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of 14 months', 'description': 'Average overall survival time in months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 28 participants who were vaccinated on this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': '43 patients with Stage IV melanoma were enrolled between November 2004 and May 2007. Fifteen of these patients did not receive any vaccine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.\n\nBystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2005-01-07', 'resultsFirstSubmitDate': '2012-10-18', 'studyFirstSubmitQcDate': '2005-01-07', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-10-18', 'studyFirstPostDateStruct': {'date': '2005-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Partial Response', 'timeFrame': 'Average of 14 months', 'description': 'Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment', 'timeFrame': 'Average of 14 months', 'description': 'Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).'}, {'measure': 'Number of Participants With Stable Disease', 'timeFrame': 'Average of 14 months', 'description': 'Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.'}, {'measure': 'Time to Progression (TTP) in Months', 'timeFrame': 'Average of 14 months', 'description': 'Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Overall Survival (OS) in Months', 'timeFrame': 'Average of 14 months', 'description': 'Average overall survival time in months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage III melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://moffitt.org/clinical-trials-research/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.", 'detailedDescription': 'The vaccine will be made by mixing two kinds of cells: 1) some of the patient\'s own malignant melanoma cells which were removed by surgery and then processed in the Cell Therapy Laboratory, and 2) experimental "bystander" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted into them. These changes are designed to help boost the patient\'s immune system to better fight the cancer in their body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed stage IIIC or stage IV melanoma\n* Measurable disease\n* Age 18 or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* No radiation therapy within 2 weeks prior to first vaccine administration\n* No chemotherapy within 4 weeks prior to first vaccine administration\n* No steroid therapy within 4 weeks prior to first vaccine administration\n* No surgery within 10 days prior to first vaccine administration\n* Patient's written informed consent\n* Patient's ability to comply with the visit schedule and assessments required by the protocol\n* Adequate organ function (measured within a week of beginning treatment):\n\n * White blood count (WBC) \\> 3,000/mm\\^3 and absolute neutrophil count (ANC) \\>1500/mm\\^3\n * Platelets \\> 100,000/mm\\^3\n * Hematocrit \\> 25% and Hgb \\> 8 g/dL\n * Bilirubin \\< 2.0 mg/dL\n * Creatinine \\< 2.0 mg/dL, or creatinine clearance \\> 60 mL/min\n\nExclusion Criteria:\n\n* Symptomatic or untreated brain metastasis\n* Any serious ongoing infection\n* Current corticosteroid or other immunosuppressive therapy\n* Any other pre-existing immunodeficiency condition (including known HIV infection)\n* Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\\*A pregnancy test will be obtained before treatment)\n* ECOG performance status of 2, 3, or 4\n* Any second active primary cancer"}, 'identificationModule': {'nctId': 'NCT00101166', 'briefTitle': 'Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma', 'orgStudyIdInfo': {'id': 'MCC-13639'}, 'secondaryIdInfos': [{'id': '0407-657', 'type': 'OTHER', 'domain': 'OBA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine Therapy', 'description': 'Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.', 'interventionNames': ['Biological: Bystander-Based Autologous Tumor Cell Vaccine']}], 'interventions': [{'name': 'Bystander-Based Autologous Tumor Cell Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['GM.CD40L', 'bystander cells', 'Melanoma Vaccine', 'Immunotherapy'], 'description': 'The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.', 'armGroupLabels': ['Vaccine Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Sophie Dessureault, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'American Society of Clinical Oncology', 'class': 'OTHER'}, {'name': 'Society of Surgical Oncology (SSO)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}