Nctid:
NCT00001512
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008223", "term"=>"Lymphoma"}, {"id"=>"D000008224", "term"=>"Lymphoma, Follicular"}, {"id"=>"D000016393", "term"=>"Lymphoma, B-Cell"}], "ancestors"=>[{"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000008228", "term"=>"Lymphoma, Non-Hodgkin"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18828", "name"=>"Lymphoma, B-Cell", "asFound"=>"B-cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M11221", "name"=>"Lymphoma, Follicular", "asFound"=>"Follicular lymphoma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T640", "name"=>"B-cell Lymphoma", "asFound"=>"B-cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T2361", "name"=>"Follicular Lymphoma", "asFound"=>"Follicular lymphoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M19117", "name"=>"Immunoglobulins, Intravenous", "relevance"=>"LOW"}, {"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}, {"id"=>"M4212", "name"=>"Antibodies, Anti-Idiotypic", "relevance"=>"LOW"}, {"id"=>"M10178", "name"=>"Immunoglobulin Idiotypes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>42}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-09-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-03-05", "completionDateStruct"=>{"date"=>"2010-03-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2017-06-30", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2017-07-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2010-03-05", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["ProMace Chemotherapy", "Indolent Lymphoma", "Anti-Idiotype Antibody", "GM-CSF", "B-Cell Lymphoma"], "conditions"=>["B Cell Lymphoma", "Follicular Lymphoma", "Lymphoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"47617", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"6173751", "type"=>"BACKGROUND", "citation"=>"Miller RA, Maloney DG, Warnke R, Levy R. Treatment of B-cell lymphoma with monoclonal anti-idiotype antibody. N Engl J Med. 1982 Mar 4;306(9):517-22. doi: 10.1056/NEJM198203043060906. No abstract available."}, {"pmid"=>"77876", "type"=>"BACKGROUND", "citation"=>"Daley MJ, Gebel HM, Lynch RG. Idiotype-specific transplantation resistance to MOPC-315: abrogation by post-immunization thymectomy. J Immunol. 1978 May;120(5):1620-4."}]}, "descriptionModule"=>{"briefSummary"=>"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. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological \"adjuvant\" is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response.\n\nThe objectives of this study are: 1) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2 oncogene).\n\nThe goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive an autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses (patients are randomized to either a high or low dose, 500 or 100 micrograms/m2).\n\nWe plan to accrue 42 patients. Twenty-nine patients have been enrolled. Sixteen patients have entered and/or completed the vaccination phase. Patients have demonstrated significant lymphoproliferative responses specific for autologous idiotype of a magnitude which is significantly greater than previously observed.", "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. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological \"adjuvant\" is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response.\n\nThe objectives of this study are: 1) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2 oncogene).\n\nThe goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive an autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\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, IgG or IgA 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\nOnly previously untreated patients are eligible.\n\nPrevious treatment with radiation alone (less than TBI) is permissible.\n\nA single peripheral lymph node of at least 2 cm size accessible for biopsy/harvest.\n\nKarnofsky status greater than or equal to 70 percent.\n\nLife expectancy of greater than 1 year.\n\nSerum creatinine less than or equal to 1.5 mg per 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 times 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\nEXCLUSION CRITERIA:\n\nPrior total body irradiation.\n\nPresence of antibodies to HIV, hepatitis B surface antigen or other active infectious process.\n\nPregnancy or lactation. Fertile men and women must plan to use 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\nPatients unwilling to give informed consent.\n\nFailure to meet any of the inclusion criteria.\n\nAny medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment will be excluded from this protocol.\n\nPatient with CNS lymphoma (current or previously treated) will not be eligible."}, "identificationModule"=>{"nctId"=>"NCT00001512", "briefTitle"=>"Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines", "nctIdAliases"=>["NCT00878488"], "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines", "orgStudyIdInfo"=>{"id"=>"960133"}, "secondaryIdInfos"=>[{"id"=>"96-C-0133"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Id-KLH Vaccine", "type"=>"DRUG"}, {"name"=>"GM-CSF", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
