Nctid:
NCT00001438
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "asFound"=>"Lymphoproliferative Disorders", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunologic Deficiency Syndromes", "relevance"=>"HIGH"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077190", "term"=>"Interferon alpha-2"}, {"id"=>"D014212", "term"=>"Tretinoin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D007641", "term"=>"Keratolytic Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M16965", "name"=>"Tretinoin", "asFound"=>"EDTA", "relevance"=>"HIGH"}, {"id"=>"M10407", "name"=>"Interferons", "relevance"=>"LOW"}, {"id"=>"M19243", "name"=>"Interferon-alpha", "relevance"=>"LOW"}, {"id"=>"M1685", "name"=>"Interferon alpha-2", "asFound"=>"Human Milk", "relevance"=>"HIGH"}, {"id"=>"M10667", "name"=>"Keratolytic Agents", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective 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"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-01", "completionDateStruct"=>{"date"=>"2000-12"}, "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"=>["HIV Infection", "Immune Response", "Pediatric", "Pharmacokinetics", "Toxicity"], "conditions"=>["HIV Infections", "Immunologic Deficiency Syndromes", "Lymphoproliferative Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"2033252", "type"=>"BACKGROUND", "citation"=>"Sidell N, Taga T, Hirano T, Kishimoto T, Saxon A. Retinoic acid-induced growth inhibition of a human myeloma cell line via down-regulation of IL-6 receptors. J Immunol. 1991 Jun 1;146(11):3809-14."}, {"pmid"=>"7918055", "type"=>"BACKGROUND", "citation"=>"Su IJ, Cheng AL, Tsai TF, Lay JD. Retinoic acid-induced apoptosis and regression of a refractory Epstein-Barr virus-containing T cell lymphoma expressing multidrug-resistance phenotypes. Br J Haematol. 1993 Dec;85(4):826-8. doi: 10.1111/j.1365-2141.1993.tb03235.x."}, {"pmid"=>"1487412", "type"=>"BACKGROUND", "citation"=>"Aviles A, Diaz-Maqueo JC, Garcia EL, Talavera A, Guzman R. Maintenance therapy with interferon alfa 2b in patients with diffuse large cell lymphoma. Invest New Drugs. 1992 Nov;10(4):351-5. doi: 10.1007/BF00944195."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with congenital or acquired immunodeficiencies are at an increased risk to develop polyclonal or oligoclonal lymphoid malignancies. Some develop a lymphoproliferative disorder that can follow a clinically aggressive course and may represent a pre-malignant lesion. Although most of these lymphoproliferative disorders are of B-cell origin, T-cell or non-B-non-T-cell processes have also been observed. The pathogenesis is only partially understood.\n\nIn the case of pre-malignant conditions it is often difficult to know when and whether a therapeutic intervention is necessary and a careful consideration of potential treatment-associated morbidity is indicated. Therapies have ranged from influencing the possible infectious etiology (by treating with acyclovir), decreasing the amount of immunosuppression (in transplant patients), to the use of immunomodulatory agents, including interferons and interleukins. Recent data have indicated that the use of differentiating agents, such as the retinoids, might offer yet another treatment option. In the current study we will try to get a better understanding of the pathogenesis and natural course of lymphoproliferative disorders in immunodeficient children.\n\nThe study will have two parts: an initial observation period to obtain information on the natural course of these disorders, and then a six month treatment period with the combination of a differentiating agent (13-cis-retinoic acid was used until all-trans-retinoic acid became available on 7/96) with an immunomodulatory agent (interferon-alpha2a, IFN-alpha2a).", "detailedDescription"=>"Patients with congenital or acquired immunodeficiencies are at an increased risk to develop polyclonal or oligoclonal lymphoid malignancies. Some develop a lymphoproliferative disorder that can follow a clinically aggressive course and may represent a pre-malignant lesion. Although most of these lymphoproliferative disorders are of B-cell origin, T-cell or non-B-non-T-cell processes have also been observed. The pathogenesis is only partially understood. The Epstein-Barr virus (EBV) is thought to play an important role but the human herpes virus type 6 (HHV-6) has been implicated as well. An imbalance in the expression of several cytokines is observed and it is currently not clear whether this sustains the aberrant proliferation or is a result thereof. In the case of pre-malignant conditions it is often difficult to know when and whether a therapeutic intervention is necessary and a careful consideration of potential treatment-associated morbidity is indicated. Therapies have ranged from influencing the possible infectious etiology (by treating with acyclovir), decreasing the amount of immunosuppression (in transplant patients), to the use of immunomodulatory agents, including interferons and interleukins. Recent data have indicated that the use of differentiating agents, such as the retinoids, might offer yet another treatment option. In the current study we will try to get a better understanding of the pathogenesis and natural course of lymphoproliferative disorders in immunodeficient children. The study will mainly be open to children infected with the human immunodeficiency virus but patients who develop a lymphoproliferative disorder post-transplant or as part of another immunodeficiency state may also be enrolled. The study will have two parts: an initial observation period to obtain information on the natural course of these disorders, and then a six month treatment period with the combination of a differentiating agent (13-cis-retinoic acid was used until all-trans-retinoic acid became available on 7/96) with an immunomodulatory agent (interferon-alpha2a, IFN-alpha2a)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nCongenital or acquired immunodeficiency (including HIV-1 infection) with a lymphoproliferative disorder (LPD) of any of the following types:\n\nSevere and/or progressive lymphadenopathy with hypergammaglobulinemia.\n\nDiffuse infiltrative lymphocytosis syndrome.\n\nClinically symptomatic pulmonary lymphoid hyperplasia/lymphocytic interstitial pneumonitis.\n\nPolyclonal B-cell LPD.\n\nNo patients with malignant lymphoma.\n\nNo active opportunistic infection requiring acute intervention at entry.\n\nTHERAPY:\n\nBiologic Therapy:\n\nAt least 30 days since immunomodulating agents or biological response modifiers, e.g.: Interleukin-2, Interferons, Growth hormone, Insulin-like growth factor 1.\n\nRequirement waived for intravenous immunoglobulins for hypogammaglobulinemia.\n\nConcurrent post-transplant immunosuppressants allowed. Doses stable for at least 4 weeks prior to entry.\n\nChemotherapy: At least 30 days since chemotherapy.\n\nEndocrine Therapy:\n\nConcurrent corticosteroids allowed only for lymphocytic interstitial pneumonitis or an autoimmune process. Doses stable for more than 4 weeks prior to entry.\n\nRadiotherapy: At least 30 days since radiotherapy.\n\nSurgery: Not specified.\n\nAntiretroviral therapy (in patients with HIV infection):\n\nApproved anti-HIV medication required.\n\nInitiated at least 8 weeks prior to entry.\n\nContinued throughout protocol treatment.\n\nProphylaxis for Pneumocystis carinii pneumonia and/or Mycobacterium avium-intracellulare allowed.\n\nMaintenance antifungal or antiviral therapy allowed.\n\nPATIENT CHARACTERISTICS:\n\nAge: Under 18.\n\nPerformance status: Not specified.\n\nOne or more of the following laboratory findings (within 4 weeks of starting retinoic acid and interferon-alpha , and which have not resolved within 2 weeks of starting):\n\nCreatinine greater than 2 times the upper limit of normal;\n\nLiver transaminases greater than 5 times the upper limit of normal (children with chronically elevated liver enzymes with a proven etiology can be enrolled, but will not be evaluable for liver toxicity); or\n\nBilirubin greater than 3 times the upper limit of normal.\n\nPatients receiving treatment for an acute infection must have completed therapy at least 14 days prior to starting therapy with retinoic acid and interferon-alpha.\n\nOTHER:\n\nAble to swallow capsules.\n\nNo requirement for drugs suspected of causing pseudotumor cerebri for which alternatives cannot be substituted, e.g.: Tetracycline, Nalidixic acid, Nitrofurantoin, Phenytoin, Lithium, Amiodarone, Vitamin A (except as a multivitamin supplement component).\n\nNo critical or clinically unstable illness.\n\nNo pregnant or nursing women.\n\nEffective contraception encouraged in fertile patients.\n\nParent or legal guardian available to give informed consent and deemed sufficiently reliable to return for followup visits.\n\nNo critically ill or critically unstable children."}, "identificationModule"=>{"nctId"=>"NCT00001438", "briefTitle"=>"A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes", "orgStudyIdInfo"=>{"id"=>"950144"}, "secondaryIdInfos"=>[{"id"=>"95-C-0144"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"all-trans-retinoic acid with IFN-alpha2a", "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"}}}}
