Nctid:
NCT00000801
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008223", "term"=>"Lymphoma"}, {"id"=>"D000008228", "term"=>"Lymphoma, Non-Hodgkin"}], "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"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "asFound"=>"Lymphoma, Non-Hodgkin", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"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"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T4686", "name"=>"Primary Central Nervous System Lymphoma", "asFound"=>"Primary Central Nervous System Lymphoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003561", "term"=>"Cytarabine"}, {"id"=>"D000003907", "term"=>"Dexamethasone"}, {"id"=>"D000003520", "term"=>"Cyclophosphamide"}, {"id"=>"D000004317", "term"=>"Doxorubicin"}, {"id"=>"C000506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D000014750", "term"=>"Vincristine"}], "ancestors"=>[{"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000000477", "term"=>"Alkylating Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000000932", "term"=>"Antiemetics"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D000005938", "term"=>"Glucocorticoids"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D000059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000050257", "term"=>"Tubulin Modulators"}, {"id"=>"D000050256", "term"=>"Antimitotic Agents"}, {"id"=>"D000050258", "term"=>"Mitosis Modulators"}], "browseLeaves"=>[{"id"=>"M1945", "name"=>"Lenograstim", "relevance"=>"LOW"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Serum", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Serum", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"Sedation", "relevance"=>"HIGH"}, {"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M6766", "name"=>"Cytarabine", "asFound"=>"Catheter", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>33}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-10", "completionDateStruct"=>{"date"=>"1998-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-10-31", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2012-11-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vincristine", "Cyclophosphamide", "Cytarabine", "Dexamethasone", "Doxorubicin", "Granulocyte Colony-Stimulating Factor", "Combined Modality Therapy", "Acquired Immunodeficiency Syndrome", "Antineoplastic Agents, Combined", "Brain Neoplasms", "Lymphoma, High-Grade", "Lymphoma, Intermediate-Grade"], "conditions"=>["Lymphoma, Non-Hodgkin", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8636771", "type"=>"BACKGROUND", "citation"=>"Schultz C, Scott C, Sherman W, Donahue B, Fields J, Murray K, Fisher B, Abrams R, Meis-Kindblom J. Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol. 1996 Feb;14(2):556-64. doi: 10.1200/JCO.1996.14.2.556."}]}, "descriptionModule"=>{"briefSummary"=>"To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population.\n\nCombined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.", "detailedDescription"=>"Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.\n\nPatients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication: Required:\n\n* PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.\n* Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.\n* Antiretroviral agent available by therapy IND.\n* MAI prophylaxis with rifabutin (in patients with CD4 counts \\< 100 cells/mm3).\n\nPatients must have:\n\n* HIV infection.\n* Primary CNS lymphoma with NO systemic involvement.\n\nPrior Medication:\n\nAllowed:\n\n* Prior corticosteroids.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.\n* Active uncontrolled infection.\n* Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.\n* Active heart disease (congestive heart failure or heart block greater than first degree on EKG).\n\nConcurrent Medication:\n\nExcluded:\n\n* Any investigational agent other than antiretroviral agents available by therapy IND.\n\nPatients with the following prior conditions are excluded:\n\n* No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin.\n* No new infectious complications within the past 2 weeks that require a change in antibiotics.\n* History of myocardial infarction within the past 3 months.\n\nPrior Medication:\n\nExcluded:\n\n* Prior chemotherapy other than for Kaposi's sarcoma."}, "identificationModule"=>{"nctId"=>"NCT00000801", "briefTitle"=>"Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma", "orgStudyIdInfo"=>{"id"=>"ACTG 252"}, "secondaryIdInfos"=>[{"id"=>"ECOG E 1493"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Filgrastim", "type"=>"DRUG"}, {"name"=>"Vincristine sulfate", "type"=>"DRUG"}, {"name"=>"Doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"Cyclophosphamide", "type"=>"DRUG"}, {"name"=>"Cytarabine", "type"=>"DRUG"}, {"name"=>"Dexamethasone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco AIDS Clinic / San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ of Colorado Health Sciences Ctr", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - West Campus", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02146", "city"=>"Brookline", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"ECOG Data Management Office", "geoPoint"=>{"lat"=>42.33176, "lon"=>-71.12116}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"29169", "city"=>"West Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Julio Arroyo", "geoPoint"=>{"lat"=>33.99349, "lon"=>-81.07398}}], "overallOfficials"=>[{"name"=>"Krigel RL", "role"=>"STUDY_CHAIR"}, {"name"=>"Von Roenn J", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
