Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-30 @ 8:04 AM
Study NCT ID:
NCT00003061
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS 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': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-13', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['primary central nervous system non-Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '14981168', 'type': 'RESULT', 'citation': 'Harder H, Holtel H, Bromberg JE, Poortmans P, Haaxma-Reiche H, Kluin-Nelemans HC, Menten J, van den Bent MJ. Cognitive status and quality of life after treatment for primary CNS lymphoma. Neurology. 2004 Feb 24;62(4):544-7. doi: 10.1212/wnl.62.4.544.'}, {'pmid': '14597741', 'type': 'RESULT', 'citation': "Poortmans PM, Kluin-Nelemans HC, Haaxma-Reiche H, Van't Veer M, Hansen M, Soubeyran P, Taphoorn M, Thomas J, Van den Bent M, Fickers M, Van Imhoff G, Rozewicz C, Teodorovic I, van Glabbeke M; European Organization for Research and Treatment of Cancer Lymphoma Group. High-dose methotrexate-based chemotherapy followed by consolidating radiotherapy in non-AIDS-related primary central nervous system lymphoma: European Organization for Research and Treatment of Cancer Lymphoma Group Phase II Trial 20962. J Clin Oncol. 2003 Dec 15;21(24):4483-8. doi: 10.1200/JCO.2003.03.108. Epub 2003 Nov 3."}, {'type': 'RESULT', 'citation': 'Kluin-Nelemans JC, Poortmans P, Haaxma-Reicher H, et al.: Final results of the EORTC phase II trial 20962 evaluating high-dose MTX-based chemotherapy followed by consolidating radiotherapy in non-Aids related primary central nervous system lymphoma. [Abstract] Blood 100 (11 pt 1): A-3071, 776a, 2002.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.', 'detailedDescription': 'OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen.\n\nOUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death.\n\nPROJECTED ACCRUAL: A maximum of 50 patients will be accrued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord No Burkitt's lymphoma or low grade T-cell lymphoma Must have at least 1 measurable lesion No AIDS-related primary central nervous system lymphoma (PCNSL) No disease confined to the eye without other localization in the CNS\n\nPATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Karnofsky 40-100% Neurological functional status 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No serious impairment of hepatic function Renal: No serious impairment of renal function Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min Cardiovascular: No serious impairment of cardiac function Other: HIV negative No congenital or acquired immunodeficiency syndrome No prior/concurrent systemic lymphoma No prior malignancy except: Adequately treated non-melanoma skin cancer Carcinoma in situ of the cervix uteri Not pregnant No severe uncontrolled infection\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent treatment with immunosuppressive drug Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroid use for less than 3 weeks allowed Radiotherapy: Not specified Surgery: No prior organ transplantation"}, 'identificationModule': {'nctId': 'NCT00003061', 'briefTitle': 'Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)', 'orgStudyIdInfo': {'id': 'EORTC-20962'}, 'secondaryIdInfos': [{'id': 'EORTC-20962'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'methotrexate', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium Medical Centre', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Rotterdam Cancer Institute', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5042 SB', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Dr. Bernard Verbeeten Instituut', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Philip Poortmans, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dr. Bernard Verbeeten Instituut'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}