Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-03 @ 6:19 AM
Study NCT ID:
NCT00005966
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'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': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-09', 'lastUpdateSubmitDate': '2009-02-04', 'studyFirstSubmitDate': '2000-07-05', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage III renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gordon MS, Manola J, Fairclough D, et al.: Low dose interferon-α2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS). A phase III study of the Eastern Cooperative Oncology Group (E2898). [Abstract] J Clin Oncol 22 (Suppl 14): A-4516, 386s, 2004.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide.\n* Compare the safety of these 2 regimens in these patients.\n* Compare the quality of life of patients treated with these 2 regimens.\n* Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year), and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on day 1.\n* Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1.\n\nTreatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past CR.\n\nQuality of life is assessed prior to randomization and then every 4 weeks through week 24.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven previously untreated metastatic or unresectable renal cell carcinoma\n\n * Retroperitoneal lymph nodes that are unresectable or those that are not resected at the investigator's discretion are considered metastatic disease\n * Prior nephrectomy allowed provided there is evidence of unresponsive metastatic disease after surgery or within one month prior to study enrollment\n* Bidimensionally measurable disease\n\n * Measurable disease must be outside any prior radiotherapy port\n* No history of brain metastases unless surgically resected or treated with gamma knife radiotherapy and currently without radiologic evidence of CNS disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Hemoglobin at least 9 g/dL (transfusion allowed)\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT no greater than 3 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No myocardial infarction within the past 6 months\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use 2 effective methods of contraception (1 highly active method and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks after study participation\n* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No uncontrolled diabetes or any other concurrent illnesses that would increase risk\n* No history of peripheral neuropathy\n* No severe depression\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy, or vaccine therapy for renal cell carcinoma\n* No prior antiangiogenesis therapy for renal cell carcinoma\n* Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)\n\nChemotherapy:\n\n* No prior chemotherapy for renal cell carcinoma\n* Chemotherapy for prior malignancy allowed\n\nEndocrine therapy:\n\n* No prior hormonal therapy for renal cell carcinoma\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 2 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* More than 7 days since prior IV antibiotics for infection"}, 'identificationModule': {'nctId': 'NCT00005966', 'briefTitle': 'Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000067949'}, 'secondaryIdInfos': [{'id': 'ECOG-2898'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL'}, {'name': 'thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5404', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Mayo Clinic Scottsdale Oncology Program', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'John Stoddard Cancer Center at Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy Medical Center-Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50316-2301', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Lutheran Hospital', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '68128-4157', 'city': 'Papillion', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Midlands Cancer Center at Midlands Community Hospital', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'MBCCOP - University of New Mexico HSC', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10466', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Our Lady of Mercy Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute at Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '54307-3453', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - St. Vincent Hospital Cancer Center, Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '34', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto de Enfermedades Neoplasicas', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '00936-7344', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hospital', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Michael S. Gordon, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}