Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-01 @ 8:52 AM
Study NCT ID:
NCT00003656
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
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'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Liver : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia : Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion reaction : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion reaction : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infusion reaction : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infusion reaction : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol/TG : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol/TG : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol/TG : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol/TG : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bone pain : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bone pain : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bone pain : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bone pain : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other pain : Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other pain : Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other pain : Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other pain : Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In 30 days after the last dose, an average of 1 year.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.'}, {'type': 'SECONDARY', 'title': 'Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Weekly ATRA-IV with recombinant interferon alfa\n\nrecombinant interferon alfa\n\ntretinoin liposome'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline and 5th week', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 portion at the RP2D of 90 mg/m2. 6 patients (12 in phase 1 w 6 at 75 mg/m2 and 6 at 90 mg/m2). This was not completed on the other 14 in phase 2 portion.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 Group', 'description': 'Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}, {'id': 'OG001', 'title': 'Phase 2 Group', 'description': 'Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}], 'classes': [{'title': '6 month', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months and 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 Group', 'description': 'Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}, {'id': 'FG001', 'title': 'Phase 2 Group', 'description': 'Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from between April 2002 and March 2005. Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1 Group', 'description': 'Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}, {'id': 'BG001', 'title': 'Phase 2 Group', 'description': 'Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Median age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '79'}, {'value': '61.1', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '75'}, {'value': '63.6', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Prior nephrectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes prior nephrectomy', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'No prior nephrectomy', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Clear cell', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Clear cell with sarcomatoid features', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Papillary', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Xp11', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unclassified', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients with metastases at the time of diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '1999-11-01', 'resultsFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-17', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Response as Measured by CT, Bone Scans, and Clinical Progression', 'timeFrame': 'After 8 weeks'}, {'measure': 'Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose', 'timeFrame': 'In 30 days after the last dose, an average of 1 year.'}], 'secondaryOutcomes': [{'measure': 'Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose', 'timeFrame': 'At baseline and 5th week'}, {'measure': 'Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response', 'timeFrame': 'At 6 months and 12 months'}]}, 'conditionsModule': {'keywords': ['stage IV renal cell cancer', 'recurrent renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'pmid': '12216088', 'type': 'BACKGROUND', 'citation': 'Goldberg JS, Vargas M, Rosmarin AS, Milowsky MI, Papanicoloau N, Gudas LJ, Shelton G, Feit K, Petrylak D, Nanus DM. Phase I trial of interferon alpha2b and liposome-encapsulated all-trans retinoic acid in the treatment of patients with advanced renal cell carcinoma. Cancer. 2002 Sep 15;95(6):1220-7. doi: 10.1002/cncr.10809.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=12216088', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.\n* Determine the toxicity of this regimen in these patients.\n* Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.\n\nOUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)\n\nPatients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.)\n\nDuring the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)\n\nPatients are followed at 30 days after the last treatment.\n\nPROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic renal cell carcinoma\n* Bidimensionally measurable disease\n* No active brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* No coagulation disorders\n\nHepatic:\n\n* Bilirubin less than 1.5 mg/dL\n* SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal\n* No clinically significant hepatic disease, including autoimmune hepatitis\n\nRenal:\n\n* Creatinine less than 2 mg/dL OR\n* Creatinine clearance greater than 50 mL/min\n* No clinically significant renal disease\n\nCardiovascular:\n\n* No clinically significant cardiac disease\n* No thrombophlebitis\n\nPulmonary:\n\n* No severe debilitating pulmonary disease\n* No pulmonary embolism\n\nOther:\n\n* No history of diabetes mellitus prone to ketoacidosis\n* No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study\n* No thyroid abnormalities that hinder maintaining thyroid function at the normal range\n* No severe infection\n* No severe malnutrition\n* No clinically significant retinal abnormalities\n* No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder\n* No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No more than 1 prior biological response modifier therapy or immunotherapy\n\nChemotherapy:\n\n* No more than 1 prior chemotherapy regimen\n\nEndocrine therapy:\n\n* No concurrent steroids\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior major surgery\n\nOther:\n\n* No prior retinoid therapy'}, 'identificationModule': {'nctId': 'NCT00003656', 'briefTitle': 'Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '9804003327'}, 'secondaryIdInfos': [{'id': 'NYWCCC-0498-209'}, {'id': 'NCI-V98-1490'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'Weekly ATRA-IV with recombinant interferon alfa', 'interventionNames': ['Biological: recombinant interferon alfa', 'Drug: tretinoin liposome']}], 'interventions': [{'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL', 'armGroupLabels': ['All subjects']}, {'name': 'tretinoin liposome', 'type': 'DRUG', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Weill Cornell Cancer Center at Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David M. Nanus, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}