Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 7:29 PM
Study NCT ID:
NCT00846833
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haploidentical NK Cell Infusion in Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D008546', 'term': 'Melanoma, Experimental'}], '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'}, {'id': 'D009374', 'term': 'Neoplasms, Experimental'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-06', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the maximum-tolerated dose of haploidentical NK cells', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To assess NK cell infusion-related toxicity', 'timeFrame': '2 years'}, {'measure': 'To evaluate response rate', 'timeFrame': '2 years'}, {'measure': 'To determine immune reconstitution after NK cell infusion', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melanoma, Experimental'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.', 'detailedDescription': 'Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical effects, because they are inhibited by self MHC class I molecules, based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using CD3+ depleting CliniMACS® system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic or relapsed malignant melanoma\n* Patients who received prior chemotherapy or immunotherapy\n* Patients who have at least one haploidentical donor willing to donate\n* ECOG performance status 0 or 1\n* 18 - 75 years\n* At least one measurable disease according to the RECIST criteria\n* Patients with 45% or more left ventricular ejection fraction\n* Patients with 50% or more predicted DLCO\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL\n* Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN\n* Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2\n* At least 3 months of expected survival\n* Patients who signed informed consent\n\nExclusion Criteria:\n\n* Patients who received other chemotherapeutic agents within 30 days prior to study enrollment\n* Patients who received adoptive cell therapy including hematopoietic stem cell transplantation\n* Patients infected with HIV, HBV, or HCV\n* Hypersensitivity to cyclophosphamide or interleukin-2\n* Patients who received organ transplantation\n* Patients who had arrhythmia or ischemic heart disease\n* Pregnant or lactating women\n* Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents'}, 'identificationModule': {'nctId': 'NCT00846833', 'briefTitle': 'Haploidentical NK Cell Infusion in Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma', 'orgStudyIdInfo': {'id': 'H-0808-024-253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclophosphamide, high-dose interleukin-2, NK cell', 'interventionNames': ['Biological: Haploidentical NK cell']}], 'interventions': [{'name': 'Haploidentical NK cell', 'type': 'BIOLOGICAL', 'description': '1. Collection of PBMCs by leukapheresis\n2. CD3+ depletion of apheresis product using CliniMACS®', 'armGroupLabels': ['Cyclophosphamide, high-dose interleukin-2, NK cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Seog Heo, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dae Seog Heo/Professor', 'oldOrganization': 'Seoul National University Hospital'}}}}