Nctid:
NCT00001439
Payload:
{"FullStudy"=>{"Rank"=>497946, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008545", "ConditionMeshTerm"=>"Melanoma"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000018358", "ConditionAncestorTerm"=>"Neuroendocrine Tumors"}, {"ConditionAncestorId"=>"D000017599", "ConditionAncestorTerm"=>"Neuroectodermal Tumors"}, {"ConditionAncestorId"=>"D000009373", "ConditionAncestorTerm"=>"Neoplasms, Germ Cell and Embryonal"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000009380", "ConditionAncestorTerm"=>"Neoplasms, Nerve Tissue"}, {"ConditionAncestorId"=>"D000018326", "ConditionAncestorTerm"=>"Nevi and Melanomas"}, {"ConditionAncestorId"=>"D000012878", "ConditionAncestorTerm"=>"Skin Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000012871", "ConditionAncestorTerm"=>"Skin Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11528", "ConditionBrowseLeafName"=>"Melanoma", "ConditionBrowseLeafAsFound"=>"Melanoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20495", "ConditionBrowseLeafName"=>"Neuroendocrine Tumors", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19845", "ConditionBrowseLeafName"=>"Neuroectodermal Tumors", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20388", "ConditionBrowseLeafName"=>"Neuroectodermal Tumors, Primitive", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12318", "ConditionBrowseLeafName"=>"Neoplasms, Germ Cell and Embryonal", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12325", "ConditionBrowseLeafName"=>"Neoplasms, Nerve Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12448", "ConditionBrowseLeafName"=>"Nevus, Pigmented", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12446", "ConditionBrowseLeafName"=>"Nevus", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20470", "ConditionBrowseLeafName"=>"Nevi and Melanomas", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15681", "ConditionBrowseLeafName"=>"Skin Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15674", "ConditionBrowseLeafName"=>"Skin Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4091", "ConditionBrowseLeafName"=>"Neuroendocrine Tumor", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4092", "ConditionBrowseLeafName"=>"Neuroepithelioma", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M2853", "InterventionBrowseLeafName"=>"Immunomodulating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17360", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8740", "InterventionBrowseLeafName"=>"Freund's Adjuvant", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"255"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"June 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 1999", "CompletionDateStruct"=>{"CompletionDate"=>"April 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"=>["Cancer", "Immunotherapy"]}, "ConditionList"=>{"Condition"=>["Melanoma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9136454", "ReferenceType"=>"background", "ReferenceCitation"=>"Rosenberg SA. Cancer vaccines based on the identification of genes encoding cancer regression antigens. Immunol Today. 1997 Apr;18(4):175-82. doi: 10.1016/s0167-5699(97)84664-6. No abstract available."}, {"ReferencePMID"=>"8931607", "ReferenceType"=>"background", "ReferenceCitation"=>"Rosenberg SA. Development of cancer immunotherapies based on identification of the genes encoding cancer regression antigens. J Natl Cancer Inst. 1996 Nov 20;88(22):1635-44. doi: 10.1093/jnci/88.22.1635."}, {"ReferencePMID"=>"9500606", "ReferenceType"=>"background", "ReferenceCitation"=>"Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.\n\nImmune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.", "DetailedDescription"=>"This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.\n\nImmune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nMetastatic melanoma that is HLA-A2 positive.\n\nNo primary melanoma of ocular or mucosal origin.\n\nMeasurable or resected metastatic disease required.\n\nPRIOR/CONCURRENT THERAPY:\n\nBIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy.\n\nCHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy.\n\nENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy.\n\nNo requirement for steroids.\n\nRADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy.\n\nSURGERY: Not specified.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance Status: ECOG 0 or 1.\n\nLife Expectancy: More than 3 months.\n\nHEMATOPOIETIC: No coagulation disorder.\n\nHEPATIC:\n\nBilirubin no greater than 2.0 mg/dL.\n\nNo Hepatitis BsAg antibody.\n\nRENAL: Creatinine no greater than 2.0 mg/dL.\n\nCARDIOVASCULAR: No major cardiovascular illness.\n\nPULMONARY: No major respiratory illness.\n\nOTHER:\n\nNo previous allergic reaction to incomplete Freund's adjuvant.\n\nHIV negative.\n\nNo active systemic infection.\n\nNot pregnant or lactating."}, "IdentificationModule"=>{"NCTId"=>"NCT00001439", "BriefTitle"=>"A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950145"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-C-0145"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"gp100 human melanoma peptide", "InterventionType"=>"Biological"}]}}, "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"}}}}}}
