Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT00291369
Status:
COMPLETED
Last Update Posted:
2006-02-16
First Post:
2006-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis
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': 'D007376', 'term': 'Interleukin-2'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'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': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 456}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2006-02-15', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Objective response rate'}, {'measure': 'Toxicity'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['Metastatic renal cell carcinoma', 'Interleukin-2', 'Interferon alfa', 'Cytokines', 'Survival'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '9562581', 'type': 'BACKGROUND', 'citation': "Negrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med. 1998 Apr 30;338(18):1272-8. doi: 10.1056/NEJM199804303381805."}, {'pmid': '12436438', 'type': 'BACKGROUND', 'citation': "Ravaud A, Delva R, Gomez F, Chevreau C, Douillard JY, Peny J, Coudert B, Negrier S; Groupe Francais d'Immunotherapie. Subcutaneous interleukin-2 and interferon alpha in the treatment of patients with metastatic renal cell carcinoma-Less efficacy compared with intravenous interleukin-2 and interferon alpha. Results of a multicenter Phase II trial from the Groupe Francais d'Immunotherapie. Cancer. 2002 Dec 1;95(11):2324-30. doi: 10.1002/cncr.10968."}, {'pmid': '12196373', 'type': 'BACKGROUND', 'citation': "Negrier S, Escudier B, Gomez F, Douillard JY, Ravaud A, Chevreau C, Buclon M, Perol D, Lasset C. Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Francais d'Immunotherapie. Ann Oncol. 2002 Sep;13(9):1460-8. doi: 10.1093/annonc/mdf257."}]}, 'descriptionModule': {'briefSummary': 'The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate chance of response in metastatic renal cell carcinoma.\n\nEligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2.\n\nThe primary objective of the study is overall survival; secondary objectives are progression-free survival, response rate, toxicity, and quality of life.', 'detailedDescription': 'The PERCY Quattro trial has been designed to evaluate the survival benefit of Interleukin-2 (IL2) and/or alpha interferon (IFN) for patients with intermediate chance of response in metastatic renal cell carcinoma.\n\nThe primary objective is overall survival, and secondary objectives are progression-free survival, response rate, toxicity, and quality of life assessed before and after induction treatment (week 10).\n\nPatients above 18 years of age are eligible if they have histologically confirmed, clearly progressive metastatic renal carcinoma, more than one metastatic organ and good performance status (Karnofsky score ≥80%), or one metastatic organ with Karnofsky score 80%, normal blood and liver functions with creatinine level \\<= 160 µmol/L.\n\nEligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2. The planned sample size is 456 patients (114 in each of the four arms). MPA is given orally as 200 mg daily. IFN is given subcutaneously as 9 million IU three times a week. IL2 is given subcutaneously on a four-week schedule: 9 million IU twice daily for five days followed by a two-day rest, then, on the following three weeks, 9 million IU twice daily for two days then 9 million IU once daily on the following three days; after a week of rest, an identical 4-week cycle is administered. IFN and IL2 combination is given using identical routes, schedules and doses except for a reduction of IFN dose to 6 million IU per injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Progressive histologically proven metastatic renal cell carcinoma.\n* Patient with only 1 metastatic site and Karnofsky = 80% or more than 1 metastatic site and Karnofsky \\>= 80%.\n* Age \\>= 18\n* No wide-field radiation therapy for 6 weeks at least.\n* No active brain metastasis.\n* Blood values within limits of normal (hematocrit \\> 30% and leukocyte count \\>= 4x109/l and platelet count \\>= 120x109/l).\n* Creatinine \\< 150 µmol/l and bilirubin \\<= normal.\n* Female patients of childbearing potential: effective method of contraception is necessary.\n* Written, voluntary, informed consent.\n\nExclusion Criteria:\n\n* Previous treatment with cytokines.\n* Only one metastatic organ and Karnofsky = 90% or 100% (inclusion in good prognosis group).\n* More than one metastatic organ (at least one metastasis to the liver) and \\<12 months between initial diagnosis and diagnosis of metastasis.\n* Active brain metastases.\n* Patient with concurrent grade III/IV heart disorder (congestive heart failure, coronary artery disease, uncontrolled hypertension, severe arrhythmia, etc) and/or stroke volume \\< 50%.\n* Severe pulmonary, hepatic, or renal disease potentially aggravated by treatment.\n* Severe concurrent infection necessitating antibiotics\n* Patient with known HIV or AIDS-related disease, or presence of HB antigen or known chronic hepatitis.\n* Previous allograft.\n* Patient under corticosteroid treatment.\n* Previous or concurrent primary malignancies at other sites (except from baso-cellular skin cancer or cervical cancer in situ)\n* Pregnant or lactating woman.\n* Follow-up difficult because of geography or personal circumstances.'}, 'identificationModule': {'nctId': 'NCT00291369', 'briefTitle': 'Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis', 'orgStudyIdInfo': {'id': 'PERCY QUATTRO'}, 'secondaryIdInfos': [{'id': 'ET99-058'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interleukin-2', 'type': 'DRUG'}, {'name': 'Interferon alfa', 'type': 'DRUG'}, {'name': 'medroxyprogesterone acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Sylvie Negrier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Immunotherapy Intergroup', 'class': 'OTHER'}, {'name': 'SCAPP (Sub-Cutaneous Administration Proleukin Program)', 'class': 'UNKNOWN'}]}}}