Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 7:09 AM
Study NCT ID:
NCT00589550
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2008-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}, {'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D007124', 'term': 'Immunoenzyme Techniques'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Thomas.Olencki@osumc.edu', 'phone': '614-293-2886', 'title': 'Thomas Olencki, DO', 'organization': 'The Ohio State University Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Trial was terminated due to low patient accrual'}}, 'adverseEventsModule': {'timeFrame': 'Baseline until study discontinuation', 'description': 'The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used to grade and quantify toxic events associated with therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 2 months', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 2 months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 1 year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 1 year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 1 year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'up to 1 year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'timeFrame': 'Up to 1 year', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrew From Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peginterferon Alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nPEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.\n\nSorafenib\n\ngene expression analysis\n\npolymerase chain reaction\n\nreverse transcriptase-polymerase chain reaction\n\nflow cytometry\n\nimmunoenzyme technique\n\nlaboratory biomarker analysis'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age18-60', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patient'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2008-01-05', 'resultsFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2008-01-05', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-04', 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate', 'timeFrame': 'up to 2 months'}, {'measure': 'Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.', 'timeFrame': 'up to 2 months'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.', 'timeFrame': 'up to 1 year'}, {'measure': 'Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.', 'timeFrame': 'up to 1 year'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 1 year'}, {'measure': 'Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome', 'timeFrame': 'up to 1 year'}, {'measure': 'Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clear cell renal cell carcinoma', 'stage III renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'Jamesline'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell carcinoma.\n\nSecondary\n\n* To determine the progression-free survival of patients treated with this regimen.\n* To evaluate, in a preliminary manner, the response rate and overall survival of patients treated with this regimen.\n* To evaluate the activation of interferon-induced transcription factors in immune cell subsets (including regulatory T cells \\[T regs\\]) using a novel flow cytometric assay and correlate this information with clinical outcome.\n* To measure circulating levels of IFN-γ and IL-5 for determination of Th1/Th2 status and CD4+, CD25+, and FoxP3 cell number (T regs) in peripheral blood.\n\nOUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, 22, 29, 36, 43, and 50. Patients also receive oral sorafenib tosylate 2-3 times daily on days 15-56 of course 1 and on days 1-56 of all subsequent courses. Courses repeat every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.\n\nBlood samples are collected at baseline and periodically during study for correlative laboratory studies. Peripheral blood mononuclear cells are analyzed for STAT proteins (STAT1, STAT2, STAT3, STAT4, STAT5) and CD4+, CD25+, and FoxP3 regulatory T cells by flow cytometric assays. Samples are also analyzed for the presence of VEGF, VEGFR, IFN-γ, and IL-5 by ELISA assays; baseline expression of Jak-STAT signaling intermediates (Jak1, Tyk2, IFNAR, and IRF9) by immunoblot analysis; and interferon-stimulated gene expression by real time PCR and RT-PCR analysis.\n\nAfter completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)\n* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan\n* No prior treatment except\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Life expectancy \\> 6 months\n* Good/intermediate Motzer prognostic status\n* ANC ≥ 1,000/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 10.0 g/dL\n* Total bilirubin ≤ 2.0 mg/dL\n* AST and ALT \\< 2.5 times normal\n* Creatinine ≤ 1.8 mg/dL OR creatinine clearance \\> 50 mL/min\n* Calcium \\< 12 mg/dL (when corrected for serum albumin)\n* INR \\< 1.5 times upper limit of normal\n* Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo\n* Pulse oximetry ≥ 90% at rest on room air\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No evidence of bleeding diathesis\n* No uncontrolled coagulation disorders\n* No active infections requiring IV antibiotics\n* No known HIV, hepatitis C, or hepatitis B\n* No autoimmune disease requiring ongoing therapy\n* No requirement for adrenal replacement\n* No angina (controlled or uncontrolled)\n* No uncontrolled hypertension\n* No history of other major medical illnesses including, but not limited to, any of the following:\n\n * Cardiac ischemia\n * Myocardial infarction\n * Major cardiac arrhythmias\n * Inflammatory bowel disorders\n* No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years\n* No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior treatment for RCC except sunitinib malate\n\n * Patients may have progressed or have been intolerant to sunitinib malate\n* No prior systemic treatment for metastatic disease (other than sunitinib malate)\n* No prior organ allografts\n* At least 2 weeks since prior laparoscopic/robotic surgery\n* At least 4 weeks since prior open nephrectomy\n* More than 4 weeks since prior and no concurrent radiotherapy or other surgery\n* More than 4 weeks since prior systemic steroids\n* More than 2 weeks since prior topical, injected, or inhaled steroids\n* No concurrent steroid therapy\n* No concurrent Hypericum perforatum (St. John's wort)"}, 'identificationModule': {'nctId': 'NCT00589550', 'briefTitle': 'PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Phase I Study Of Peginterferon Alfa-2b (PEG-INTRON) With Sorafenib (Nexavar) In Patients With Unresectable Or Metastatic Clear Cell Renal Carcinoma (RCC).', 'orgStudyIdInfo': {'id': 'OSU-06113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peginterferon alfa-2b', 'description': 'Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.', 'interventionNames': ['Biological: PEG-interferon alfa-2b', 'Drug: Sorafenib', 'Genetic: gene expression analysis', 'Genetic: polymerase chain reaction', 'Genetic: reverse transcriptase-polymerase chain reaction', 'Other: flow cytometry', 'Other: immunoenzyme technique', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'PEG-interferon alfa-2b', 'type': 'BIOLOGICAL', 'otherNames': ['peginterferon alfa-2b'], 'description': 'administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar', 'BAY 54-9085 is the tosylate salt of BAY 43-9006'], 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'gene expression analysis', 'type': 'GENETIC', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'flow cytometry', 'type': 'OTHER', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'immunoenzyme technique', 'type': 'OTHER', 'armGroupLabels': ['Peginterferon alfa-2b']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Peginterferon alfa-2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Thomas E. Olencki, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Olencki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Schering-Plough', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas Olencki', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}