A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Nctid: NCT00001573

Payload: {"FullStudy"=>{"Rank"=>497837, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012509", "ConditionMeshTerm"=>"Sarcoma"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000018204", "ConditionAncestorTerm"=>"Neoplasms, Connective and Soft Tissue"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9020", "ConditionBrowseLeafName"=>"Glioma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15327", "ConditionBrowseLeafName"=>"Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20350", "ConditionBrowseLeafName"=>"Neoplasms, Connective and Soft Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2519", "ConditionBrowseLeafName"=>"Glioma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5284", "ConditionBrowseLeafName"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M1776", "InterventionBrowseLeafName"=>"Leflunomide", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"30"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"February 2000", "CompletionDateStruct"=>{"CompletionDate"=>"May 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Glioma", "PDGF", "Pharmacokinetics", "Sarcoma", "Toxicity"]}, "ConditionList"=>{"Condition"=>["Glioma", "Sarcoma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8586462", "ReferenceType"=>"background", "ReferenceCitation"=>"Westermark B, Heldin CH, Nister M. Platelet-derived growth factor in human glioma. Glia. 1995 Nov;15(3):257-63. doi: 10.1002/glia.440150307."}, {"ReferencePMID"=>"2164040", "ReferenceType"=>"background", "ReferenceCitation"=>"Maxwell M, Naber SP, Wolfe HJ, Galanopoulos T, Hedley-Whyte ET, Black PM, Antoniades HN. Coexpression of platelet-derived growth factor (PDGF) and PDGF-receptor genes by primary human astrocytomas may contribute to their development and maintenance. J Clin Invest. 1990 Jul;86(1):131-40. doi: 10.1172/JCI114675."}, {"ReferencePMID"=>"8376577", "ReferenceType"=>"background", "ReferenceCitation"=>"Matsui T, Sano K, Tsukamoto T, Ito M, Takaishi T, Nakata H, Nakamura H, Chihara K. Human neuroblastoma cells express alpha and beta platelet-derived growth factor receptors coupling with neurotrophic and chemotactic signaling. J Clin Invest. 1993 Sep;92(3):1153-60. doi: 10.1172/JCI116684."}]}}, "DescriptionModule"=>{"BriefSummary"=>"A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at each dose level. MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity.\n\nEach treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4.", "DetailedDescription"=>"SU101 is a member of a novel class of antineoplastic agents, platelet-derived growth factor (PDGF) receptor inhibitors. Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas. A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent. In addition, we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery.\n\nPRIOR/CONCURRENT THERAPY:\n\nRecovered from toxic affects of all prior therapy.\n\nNo investigational agent within past 2 weeks.\n\nBIOLOGY THERAPY: Not specified.\n\nCHEMOTHERAPY:\n\nNo myelosuppressive therapy within past 3 weeks.\n\nNo nitrosourea within past 6 weeks.\n\nENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks.\n\nRADIOTHERAPY: Not specified.\n\nSURGERY: Not specified.\n\nPATIENT CHARACTERISTICS:\n\nAge: 3 to 21.\n\nPerformance status: ECOG 0-2.\n\nLife expectancy: At least 8 weeks.\n\nHEMATOPOIETIC:\n\nAGC greater than 1500/mm(3).\n\nHemoglobin greater than or equal to 8.0 g/dL percent.\n\nPlatelet count greater than 100,000/mm(3).\n\nFor patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3).\n\nHEPATIC:\n\nSGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal.\n\nBilirubin no less than or equal to 1.5 times upper limit of normal.\n\nRENAL:\n\nAges 3-5 Creatinine no greater than 0.8 mg/dL.\n\nAges 5-10 Creatinine no greater than 1.0 mg/dL.\n\nAges 10-15 Creatinine no greater than 1.2 mg/dL.\n\nAges 16-21 Creatinine no greater than 1.5 mg/dL.\n\nOTHER:\n\nAll patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study.\n\nFor patients with brain tumors who are over 18 years of age, a DPA should be signed.\n\nNot pregnant or nursing.\n\nNot allergic to etoposide.\n\nNo acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results."}, "IdentificationModule"=>{"NCTId"=>"NCT00001573", "BriefTitle"=>"A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970087"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-C-0087"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"SU101", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}