Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-09 @ 4:38 PM
Study NCT ID:
NCT01925118
Status:
TERMINATED
Last Update Posted:
2016-04-26
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Ineffectiveness', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-week modified immune-related response rate', 'timeFrame': '12-week'}], 'secondaryOutcomes': [{'measure': '6-week modified immune-related response rate', 'timeFrame': '6-week'}, {'measure': 'Overall response rate based on RECIST v1.1', 'timeFrame': '6/12-week'}, {'measure': 'Progression-free survival', 'timeFrame': '6-month'}, {'measure': 'Overall survival', 'timeFrame': '1-year'}, {'measure': 'Immune-related adverse events', 'timeFrame': '12-week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Malignant Melanoma and Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed malignant melanoma or renal cell carcinoma\n* At stage IV or relapse\n* At least one prior chemotherapy including targeted agents\n* At least one haploidential or partially matched-HLA donor\n* ECOG performance status 0-1\n* Age 18-75 years\n* Measurable lesion\n* Adequate bone marrow, liver, and renal functions\n\nExclusion Criteria:\n\n* Chemotherapy within 4 weeks\n* Stem cell transplantation\n* Active CNS metastasis\n* Hypersensitivity to IL-2'}, 'identificationModule': {'nctId': 'NCT01925118', 'briefTitle': 'Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'H-1305-6130491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose IL-2', 'interventionNames': ['Biological: Irradiated donor lymphocyte infusion']}], 'interventions': [{'name': 'Irradiated donor lymphocyte infusion', 'type': 'BIOLOGICAL', 'armGroupLabels': ['High-dose IL-2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Seog Heo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}