Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 11:12 PM
Study NCT ID:
NCT00502034
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D008222', 'term': 'Lymphokines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-16', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.'}], 'secondaryOutcomes': [{'measure': 'Tolerability, toxicity and safety.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinoma, Renal Cell', 'Low-dose Interleukin', 'Adjuvant Immunotherapy'], 'conditions': ['Carcinoma, Renal Cell']}, 'referencesModule': {'references': [{'pmid': '17069530', 'type': 'BACKGROUND', 'citation': 'Passalacqua R, Buti S, Tomasello G, Longarini R, Brighenti M, Dalla Chiesa M. Immunotherapy options in metastatic renal cell cancer: where we are and where we are going. Expert Rev Anticancer Ther. 2006 Oct;6(10):1459-72. doi: 10.1586/14737140.6.10.1459.'}, {'pmid': '15481703', 'type': 'BACKGROUND', 'citation': 'Giacosa R, Santi R, Vaglio A, Pavone L, Ferrozzi F, Passalacqua R, Buzio C. "Late" regressions of metastases from renal cancer after a period of disease progression continuing the same intermittent low dose immunotherapy regimen. Acta Biomed. 2004 Aug;75(2):126-30.'}, {'pmid': '11745283', 'type': 'BACKGROUND', 'citation': 'Buzio C, Andrulli S, Santi R, Pavone L, Passalacqua R, Potenzoni D, Ferrozzi F, Giacosa R, Vaglio A. Long-term immunotherapy with low-dose interleukin-2 and interferon-alpha in the treatment of patients with advanced renal cell carcinoma. Cancer. 2001 Nov 1;92(9):2286-96. doi: 10.1002/1097-0142(20011101)92:93.0.co;2-i.'}, {'pmid': '9275034', 'type': 'BACKGROUND', 'citation': 'Buzio C, De Palma G, Passalacqua R, Potenzoni D, Ferrozzi F, Cattabiani MA, Manenti L, Borghetti A. Effectiveness of very low doses of immunotherapy in advanced renal cell cancer. Br J Cancer. 1997;76(4):541-4. doi: 10.1038/bjc.1997.422.'}, {'pmid': '25304727', 'type': 'DERIVED', 'citation': 'Passalacqua R, Caminiti C, Buti S, Porta C, Camisa R, Braglia L, Tomasello G, Vaglio A, Labianca R, Rondini E, Sabbatini R, Nastasi G, Artioli F, Prati A, Potenzoni M, Pezzuolo D, Oliva E, Alberici F, Buzio C; POLAR-01 Trial Investigators. Adjuvant low-dose interleukin-2 (IL-2) plus interferon-alpha (IFN-alpha) in operable renal cell carcinoma (RCC): a phase III, randomized, multicentre trial of the Italian Oncology Group for Clinical Research (GOIRC). J Immunother. 2014 Nov-Dec;37(9):440-7. doi: 10.1097/CJI.0000000000000055.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.', 'detailedDescription': 'For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT) using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically repeated doses of IL2 plus IFN induce a persistent stimulation of the immune system with no relevant toxicity.\n\nSurgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1 million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years. Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological diagnosis of RCC, age \\<75 yrs, radical or partial nephrectomy within the past 3 months, pT1 (diameter of T \\> 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no autoimmune disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis histologically confirmed of renal cells carcinoma (every histotype);\n* Age \\< 75 years\n* Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months\n* Patient classified as T1 (with diameter \\> 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy\n* Absence of distant metastases;\n* Written informed consent\n\nExclusion Criteria:\n\n* Tumor diameter equal or less than 2,5 cm;\n* Previous chemotherapy or ormonotherapy o immunotherapy;\n* Renal insufficiency \\>3 mg/dl);\n* No symptomatic arrhythmias or autoimmune disease'}, 'identificationModule': {'nctId': 'NCT00502034', 'briefTitle': 'Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Oncologico Italiano di Ricerca Clinica'}, 'officialTitle': 'Adjuvant Low-dose Interleukin-2 (IL2) Plus Interferone-alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC).', 'orgStudyIdInfo': {'id': 'POLAR 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-immunotherapy', 'description': 'Immunotherapy with interferon-alpha and interleukin', 'interventionNames': ['Drug: Interferon Alfa-2a', 'Drug: Interleukin-2']}, {'type': 'NO_INTERVENTION', 'label': 'B-follow-up', 'description': 'Wait-and-see'}], 'interventions': [{'name': 'Interferon Alfa-2a', 'type': 'DRUG', 'description': 'Interferon Alfa-2a in combination with Interleukin', 'armGroupLabels': ['A-immunotherapy']}, {'name': 'Interleukin-2', 'type': 'DRUG', 'description': 'Interferon Alfa-2a in combination with Interleukin', 'armGroupLabels': ['A-immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41012', 'city': 'Carpi', 'state': 'Modena', 'country': 'Italy', 'facility': 'Carpi Hospital', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Istituti Ospitalieri di Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Modena University Hospital', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Parma University Hospital', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Pavia University Hospital', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '29100', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Ospedale "Guglielmo da Saliceto"', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Rodolfo Passalacqua, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Gruppo Oncologico Italiano di Ricerca Clinica'}, {'name': 'Carlo Buzio, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Parma University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Oncologico Italiano di Ricerca Clinica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}