Nctid:
NCT00001572
Payload:
{"FullStudy"=>{"Rank"=>497838, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008223", "ConditionMeshTerm"=>"Lymphoma"}, {"ConditionMeshId"=>"D000008224", "ConditionMeshTerm"=>"Lymphoma, Follicular"}, {"ConditionMeshId"=>"D000016393", "ConditionMeshTerm"=>"Lymphoma, B-Cell"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000008232", "ConditionAncestorTerm"=>"Lymphoproliferative Disorders"}, {"ConditionAncestorId"=>"D000008206", "ConditionAncestorTerm"=>"Lymphatic Diseases"}, {"ConditionAncestorId"=>"D000007160", "ConditionAncestorTerm"=>"Immunoproliferative Disorders"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000008228", "ConditionAncestorTerm"=>"Lymphoma, Non-Hodgkin"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11220", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11221", "ConditionBrowseLeafName"=>"Lymphoma, Follicular", "ConditionBrowseLeafAsFound"=>"Follicular lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18828", "ConditionBrowseLeafName"=>"Lymphoma, B-Cell", "ConditionBrowseLeafAsFound"=>"B-cell Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11225", "ConditionBrowseLeafName"=>"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11203", "ConditionBrowseLeafName"=>"Lymphatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10206", "ConditionBrowseLeafName"=>"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11222", "ConditionBrowseLeafName"=>"Lymphoma, Non-Hodgkin", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T2361", "ConditionBrowseLeafName"=>"Follicular Lymphoma", "ConditionBrowseLeafAsFound"=>"Follicular lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T640", "ConditionBrowseLeafName"=>"B-cell Lymphoma", "ConditionBrowseLeafAsFound"=>"B-cell Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000078785", "InterventionMeshTerm"=>"Saponin QA-21V1"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000276", "InterventionAncestorTerm"=>"Adjuvants, Immunologic"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10184", "InterventionBrowseLeafName"=>"Immunoglobulins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19117", "InterventionBrowseLeafName"=>"Immunoglobulins, Intravenous", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4225", "InterventionBrowseLeafName"=>"Antibodies", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17360", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10178", "InterventionBrowseLeafName"=>"Immunoglobulin Idiotypes", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M259654", "InterventionBrowseLeafName"=>"Saponin QA-21V1", "InterventionBrowseLeafAsFound"=>"CYP2C19", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3628", "InterventionBrowseLeafName"=>"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"21"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 30, 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2, 2010", "CompletionDateStruct"=>{"CompletionDate"=>"November 2, 2010", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"June 30, 2017", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"July 2, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"July 31, 1999", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["B-Cell Lymphoma", "BCL- 2 Positive Tumor", "Immunization", "Induction Chemotherapy", "Lymphoma Vaccine", "Follicular Lymphoma", "Tumor-Derived Immunoglobulin Idiotype"]}, "ConditionList"=>{"Condition"=>["B Cell Lymphoma", "Follicular Lymphoma", "Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"47617", "ReferenceType"=>"background", "ReferenceCitation"=>"Stevenson GT, Stevenson FK. Antibody to a molecularly-defined antigen confined to a tumour cell surface. Nature. 1975 Apr 24;254(5502):714-6. doi: 10.1038/254714a0. No abstract available."}, {"ReferencePMID"=>"4108872", "ReferenceType"=>"background", "ReferenceCitation"=>"Sirisinha S, Eisen HN. Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins. Proc Natl Acad Sci U S A. 1971 Dec;68(12):3130-5. doi: 10.1073/pnas.68.12.3130."}, {"ReferencePMID"=>"1406793", "ReferenceType"=>"background", "ReferenceCitation"=>"Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15. doi: 10.1056/NEJM199210223271705."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Patients undergo chemotherapy until remission is obtained, or disease has been stable for two cycles of chemotherapy, or progressive disease develops.\n\nThree to six months after completion of chemotherapy, patients who have achieved complete clinical remission or minimal disease status receive a series of 5 injections (given 1-2 months apart) of a vaccine consisting of 0.5 mg autologous tumor-derived immunoglobulin (Id) conjugated to KLH. The vaccine is administered with subcutaneous QS-21 as an immunological adjuvant....", "DetailedDescription"=>"The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with an emulsion-based adjuvant.\n\nThe objectives of this study are: 1) to evaluate feasibility and toxicity of new vaccine formulations, and 2) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma.\n\nThe goal of this study is to treat patients with follicular lymphomas to complete remission or minimal residual disease with chemotherapy. Six to twelve months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive one of two new formulations of an autologous Id vaccine."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nSample size: up to 30 patients.\n\nSex distribution: Male and female.\n\nAge: Patients must be greater than or equal to 18 years old.\n\nPatients must meet all of the following eligibility criteria:\n\nTissue diagnosis of: follicular small cleaved cell or follicular mixed lymphoma with surface IgM, IgA, or IgG phenotype with a monoclonal heavy and light chain. Pathology slides must be submitted to the NIH Pathology Department for review.\n\nStage III or IV lymphoma.\n\nA single peripheral lymph node of at least 2x2 to 3x3 cm size and accessible for biopsy/harvest.\n\nKarnofsky status greater than or equal to 70%.\n\nLife expectancy of greater than 1 year.\n\nSerum creatinine less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma.\n\nBilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or Gilbert's disease. SGOT/SGPT less than or equal to 3.5 x upper limit of normal.\n\nAbility to give informed consent. Ability to return to clinic for adequate follow-up for the period that the protocol requires.\n\nThere are no gender or racial / ethnic restrictions on patient selection. This protocol is open to all genders and racial / ethnic groups.\n\nEXCLUSION CRITERIA:\n\nThe presence of any exclusion criteria (listed below) will prohibit entry onto study:\n\nPrior total body irradiation.\n\nPresence of antibodies to HIV or hepatitis B surface antigen or other active infectious process.\n\nPregnant or lactation. Fertile men and women must plan to use an effective contraception. A beta-HCG level will be obtained in women of child-bearing potential.\n\nPatients with previous or concomitant malignancy, regardless of site, except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix.\n\nPatient unwilling to give informed consent.\n\nFailure to meet any of the eligibility criteria in Section 3.2.\n\nAny medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment.\n\nPatients with CNS lymphoma (current or previously treated) will not be eligible."}, "IdentificationModule"=>{"NCTId"=>"NCT00001572", "BriefTitle"=>"Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00878410"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"970077"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-C-0077"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Id-KLH Vaccine", "InterventionType"=>"Drug"}, {"InterventionName"=>"QS-21 (Stimulation-QS-21) Drug", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}
