Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:00 AM
Study NCT ID:
NCT00248534
Status:
TERMINATED
Last Update Posted:
2018-09-04
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfisher@jhmi.edu', 'phone': '410-955-3657', 'title': 'Lauren Abrey, MD', 'organization': 'North American Brain Tumor Consortium'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'slow accrual, preliminary analysis suggesting futility and combining of consortia, trial closed early'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles', 'otherNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'liver enzyme elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hematotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'Objective response rate of the combination of Rituximab and TMZ', 'unitOfMeasure': 'percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Alive at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient died prematurely, one patient withdrew consent before first scan (during induction), 13 patients came off study due to progression of disease.'}, {'type': 'SECONDARY', 'title': '1 Year Overall Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-month Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '35'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Scan at 6 months\n\nComplete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks\n\nPartial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.\n\nProgressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.\n\nStable disease: Clinical status and MRI does not qualify for complete response, partial response or progression', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'patients enrolled from 2005 through 2008. Patients enrolled in an outpatient multi-institutional clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression\n\nrituximab: given IV days 1,8, 15 and 22\n\nmethylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)\n\ntemozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Karnofsky Performance Status Scale', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'description': 'Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'slow accrual/lack of resources/low priority due to combining 2 consortia', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2005-11-03', 'resultsFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-28', 'studyFirstPostDateStruct': {'date': '2005-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Objective Response', 'timeFrame': '2 months', 'description': 'Objective response rate of the combination of Rituximab and TMZ'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Alive at 3 Years', 'timeFrame': '3 years', 'description': 'The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.'}, {'measure': '1 Year Overall Survival Rate', 'timeFrame': '1 year'}, {'measure': '6-month Progression-free Survival', 'timeFrame': '6 months', 'description': 'Scan at 6 months\n\nComplete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks\n\nPartial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.\n\nProgressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.\n\nStable disease: Clinical status and MRI does not qualify for complete response, partial response or progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary central nervous system non-Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Nayak L, Abrey LE, Drappatz J, et al.: Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. [Abstract] J Clin Oncol 29 (Suppl 15): A-2039, 2011.'}, {'pmid': '22656234', 'type': 'DERIVED', 'citation': 'Nayak L, Abrey LE, Drappatz J, Gilbert MR, Reardon DA, Wen PY, Prados M, Deangelis LM, Omuro A; North American Brain Tumor Consortium. Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma. Leuk Lymphoma. 2013 Jan;54(1):58-61. doi: 10.3109/10428194.2012.698736. Epub 2012 Jul 9.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma.\n\nPURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with recurrent primary CNS non-Hodgkin's lymphoma treated with rituximab, temozolomide, and methylprednisolone.\n\nSecondary\n\n* Determine the overall and 6-month progression-free survival of patients treated with this regimen.\n\nOUTLINE: Induction therapy: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with stable disease or better proceed to consolidation therapy.\n\nConsolidation therapy: Patients receive oral temozolomide daily on days 1-5. Treatment repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed to maintenance therapy.\n\nMaintenance therapy: Patients receive methylprednisolone IV over 2 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 13.3 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy\n\n * Recurrent disease\n* Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan\n\n * Radiographical evidence of tumor progression by MRI or CT scan\n * Steroid therapy must be stable for 5 days prior to scan\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* More than 8 weeks\n\nHematopoietic\n\n* WBC ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10 g/dL (transfusion allowed)\n\nHepatic\n\n* SGOT \\< 2 times upper limit of normal (ULN)\n* Bilirubin \\< 2 times ULN\n* No active or latent hepatitis B infection\n\nRenal\n\n* Creatinine \\< 1.5 mg/dL OR\n* Creatinine clearance ≥ 60 mL/min\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No uncontrolled significant medical illness that would preclude study treatment\n* No active infection\n* No active HIV infection\n* No concurrent disease that would dangerously alter drug metabolism or obscure toxicity\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 7 days since prior interferon or thalidomide\n* No concurrent prophylactic filgrastim (G-CSF)\n* No concurrent immunotherapy\n\nChemotherapy\n\n* No prior temozolomide\n* At least 14 days since prior methotrexate\n* At least 21 days since prior procarbazine\n* At least 42 days since prior nitrosoureas\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* At least 7 days since prior tamoxifen\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* Recovered from all prior therapy\n* At least 28 days since prior investigational agents\n* At least 28 days since other prior cytotoxic therapy\n* At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)\n* No other concurrent investigational drugs"}, 'identificationModule': {'nctId': 'NCT00248534', 'briefTitle': "Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma', 'orgStudyIdInfo': {'id': 'NABTC05-01'}, 'secondaryIdInfos': [{'id': 'NABTC-05-01'}, {'id': 'CDR0000445289', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-2012-02673', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'U01CA062399', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062399', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Rituximab', 'description': 'IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.\n\nInduction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \\[TMZ\\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression', 'interventionNames': ['Biological: rituximab', 'Drug: methylprednisolone', 'Drug: temozolomide']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'description': 'given IV days 1,8, 15 and 22', 'armGroupLabels': ['IV Rituximab']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'description': '2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)', 'armGroupLabels': ['IV Rituximab']}, {'name': 'temozolomide', 'type': 'DRUG', 'otherNames': ['TMZ'], 'description': 'Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles', 'armGroupLabels': ['IV Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hillman Cancer Center at University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M. D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78284-6220', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Lauren E. Abrey, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}