Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT00003261
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-10', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy'}, {'measure': 'Toxicity'}, {'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['AIDS-related primary CNS lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.\n* Evaluate the toxicity and overall survival of these patients.\n\nOUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily.\n\nPatients are followed every 3 months for 1 year and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: This study will accrue 14 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS\n* No systemic lymphoma\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* WHO 0-3\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3000/mm\\^3\n* Platelet count at least 80,000/mm\\^3\n\nHepatic:\n\n* No serious impairment of liver function\n\nRenal:\n\n* No serious impairment of renal function\n* Creatinine clearance at least 40 mL/min\n\nCardiovascular:\n\n* No serious impairment of cardiac function\n\nNeurologic:\n\n* Neurological functional status 0-3\n\nOther:\n\n* No prior or active CNS-opportunistic infections\n* No AIDS dementia complex\n* No active systemic infections\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy"}, 'identificationModule': {'nctId': 'NCT00003261', 'briefTitle': 'Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy', 'orgStudyIdInfo': {'id': 'CDR0000066153'}, 'secondaryIdInfos': [{'id': 'ITA-GICAT-POS1'}, {'id': 'EU-97018'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'methotrexate', 'type': 'DRUG'}, {'name': 'zidovudine', 'type': 'DRUG'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33081', 'city': 'Aviano', 'country': 'Italy', 'facility': 'Centro di Riferimento Oncologico - Aviano', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}], 'overallOfficials': [{'name': 'Umberto Tirelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro di Riferimento Oncologico - Aviano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}}}}