Nctid:
NCT00001509
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009447", "term"=>"Neuroblastoma"}, {"id"=>"D000009396", "term"=>"Wilms Tumor"}], "ancestors"=>[{"id"=>"D000018241", "term"=>"Neuroectodermal Tumors, Primitive, Peripheral"}, {"id"=>"D000018242", "term"=>"Neuroectodermal Tumors, Primitive"}, {"id"=>"D000018302", "term"=>"Neoplasms, Neuroepithelial"}, {"id"=>"D000017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D000009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D000018193", "term"=>"Neoplasms, Complex and Mixed"}, {"id"=>"D000007680", "term"=>"Kidney Neoplasms"}, {"id"=>"D000014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009386", "term"=>"Neoplastic Syndromes, Hereditary"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M12391", "name"=>"Neuroblastoma", "asFound"=>"Neuroblastoma", "relevance"=>"HIGH"}, {"id"=>"M12341", "name"=>"Wilms Tumor", "asFound"=>"Wilms Tumor", "relevance"=>"HIGH"}, {"id"=>"M20387", "name"=>"Neuroectodermal Tumors, Primitive, Peripheral", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M20446", "name"=>"Neoplasms, Neuroepithelial", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"M10703", "name"=>"Kidney Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12331", "name"=>"Neoplastic Syndromes, Hereditary", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"T4085", "name"=>"Neuroblastoma", "asFound"=>"Neuroblastoma", "relevance"=>"HIGH"}, {"id"=>"T5932", "name"=>"Wilms' Tumor", "asFound"=>"Wilms Tumor", "relevance"=>"HIGH"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014212", "term"=>"Tretinoin"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000007641", "term"=>"Keratolytic Agents"}, {"id"=>"D000003879", "term"=>"Dermatologic Agents"}], "browseLeaves"=>[{"id"=>"M16965", "name"=>"Tretinoin", "asFound"=>"Laboratory biomarker analysis", "relevance"=>"HIGH"}, {"id"=>"M10407", "name"=>"Interferons", "relevance"=>"LOW"}, {"id"=>"M19243", "name"=>"Interferon-alpha", "relevance"=>"LOW"}, {"id"=>"M1685", "name"=>"Interferon alpha-2", "relevance"=>"LOW"}, {"id"=>"M10667", "name"=>"Keratolytic Agents", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-07"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-06", "completionDateStruct"=>{"date"=>"2000-05"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Differentiation", "N-myc Expression", "Retinoid", "Solid Tumor", "Trk Expression"], "conditions"=>["Nephroblastoma", "Neuroblastoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1403049", "type"=>"BACKGROUND", "citation"=>"Smith MA, Adamson PC, Balis FM, Feusner J, Aronson L, Murphy RF, Horowitz ME, Reaman G, Hammond GD, Fenton RM, et al. Phase I and pharmacokinetic evaluation of all-trans-retinoic acid in pediatric patients with cancer. J Clin Oncol. 1992 Nov;10(11):1666-73. doi: 10.1200/JCO.1992.10.11.1666."}, {"pmid"=>"1569455", "type"=>"BACKGROUND", "citation"=>"Smith MA, Parkinson DR, Cheson BD, Friedman MA. Retinoids in cancer therapy. J Clin Oncol. 1992 May;10(5):839-64. doi: 10.1200/JCO.1992.10.5.839."}, {"pmid"=>"7738627", "type"=>"BACKGROUND", "citation"=>"Adamson PC, Bailey J, Pluda J, Poplack DG, Bauza S, Murphy RF, Yarchoan R, Balis FM. Pharmacokinetics of all-trans-retinoic acid administered on an intermittent schedule. J Clin Oncol. 1995 May;13(5):1238-41. doi: 10.1200/JCO.1995.13.5.1238."}]}, "descriptionModule"=>{"briefSummary"=>"A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when used in combination, show enhanced activity in both adult and pediatric tumor cell lines.\n\nThe combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative, immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies.", "detailedDescription"=>"A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when used in combination, show enhanced activity in both adult and pediatric tumor cell lines. In the pediatric phase I trial which administered ATRA for 3 consecutive days/week repeated weekly, the AUC of ATRA decreased on day 1 to day 3 of drug administration but returned to day 1 levels at the beginning of subsequent weeks. This intermittent schedule of ATRA administration allowed for exposure to relatively high plasma concentrations of ATRA on a repetitive basis. The combination of ATRA/IFN-alpha 2a has demonstrated clinical activity in the pediatric phase I trial in neuroblastoma and Wilms' tumor. The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative, immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"AGE:\n\nAll patients must be less than or equal to 21 years of age.\n\nPERFORMANCE STATUS:\n\nPatients should have an ECOG performance status of 0, 1, or 2, and a life expectancy of at least 8 weeks.\n\nHISTOLOGIC DIAGNOSIS:\n\nPatients with the following diagnosis, confirmed by appropriate histologic examination, will be eligible for this study: neuroblastoma and Wilms' tumor.\n\nMEASURABLE DISEASE:\n\nPatients must have measurable disease. Patients with evaluable disease only (i.e., limited to positive bone scan or bone marrow) are eligible only if the bone involvement is measurable by alternative imaging modalities (MRI, CT, or plain film).\n\nPROGRESSIVE DISEASE:\n\nPatients must have evidence of progressive disease following or during prior therapy.\n\nHEMATOLOGIC FUNCTION:\n\nPatients do not have to be evaluable for hematologic toxicity to be enrolled onto the study. Patients without bone marrow involvement by tumor, with no history of BMT, and with no prior cranio-spinal or pelvic radiation, will be considered evaluable for hematologic toxicity.\n\nPatients evaluable for hematologic toxicity must have adequate bone marrow function (defined as peripheral absolute granulocyte count of greater than 1500/mm(3), hemoglobin greater than 8.0 gm% and platelet count greater than 100,000/mm(3)).\n\nHEPATIC FUNCTION:\n\nPatients must have adequate liver function (bilirubin less than 2.0 mg%; SGPT less than 2 times normal).\n\nRENAL FUNCTION:\n\nPatients must have adequate renal function defined as a creatinine clearance greater than or equal to 70 ml/min/1.732 or a serum creatinine based on age as follows:\n\nequal to or less than 5 years old: maximum serum creatinine 0.8;\n\nolder than 5 but equal to or less than 10: 1.0;\n\nolder than 10 but equal to or less than 15: 1.2;\n\nolder than 15: 1.5.\n\nRECOVERY FROM PRIOR THERAPY:\n\nPatients must have recovered from the toxic effects of prior therapy, and must be off of all chemotherapy for a minimum of two weeks prior to entry onto the protocol (a minimum of six weeks for prior nitrosoureas).\n\nINFORMED CONSENT:\n\nAll patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.\n\nNo history of CNS malignant disease, hydro-cephalus, or pseudotumor cerebri.\n\nNo history of treatment with 13-cis retinoic acid within the prior three months.\n\nWomen of childbearing potential must not be pregnant or lactating."}, "identificationModule"=>{"nctId"=>"NCT00001509", "briefTitle"=>"A Phase II Trial of All-Trans-Retinoic Acid in Combination With Interferon-Alpha 2a in Children With Recurrent Neuroblastoma or Wilms' Tumor", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase II Trial of All-Trans-Retinoic Acid in Combination With Interferon-Alpha 2a in Children With Recurrent Neuroblastoma or Wilms' Tumor", "orgStudyIdInfo"=>{"id"=>"960117"}, "secondaryIdInfos"=>[{"id"=>"96-C-0117"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"IFN-alpha with retinoic acid", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}