Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00100802
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2005-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008130', 'term': 'Lomustine'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreporingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Serious adverse events, only eligible patients are considered. 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Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Radiation recall reaction (dermatologic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 59, 'numAffected': 59}], 'organSystem': 'Investigations'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 56, 'numAffected': 56}], 'organSystem': 'Investigations'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Investigations'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Glucose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'IVth nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nervous system disorders - 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Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. 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Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.\n\nlomustine: Capsule\n\ntemozolomide: Capsule\n\nadjuvant therapy\n\nradiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy', 'description': 'Number of deaths due to complications of protocol therapy.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': '106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up', 'description': 'Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.\n\nlomustine: Capsule\n\ntemozolomide: Capsule\n\nadjuvant therapy\n\nradiation therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Surgery, Chemoradiotherapy, Rest, Maintenance, FUP', 'description': 'Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.\n\nlomustine: Capsule\n\ntemozolomide: Capsule\n\nadjuvant therapy\n\nradiation therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2005-01-06', 'resultsFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2005-01-06', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-18', 'studyFirstPostDateStruct': {'date': '2005-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One Year Overall Survival', 'timeFrame': 'One year', 'description': 'Estimated one year survival using the Kaplan-Meier methodology.'}, {'measure': 'Occurrence of Death Attributable to Complications of Protocol Therapy', 'timeFrame': 'While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy', 'description': 'Number of deaths due to complications of protocol therapy.'}]}, 'conditionsModule': {'conditions': ['Anaplastic Astrocytoma', 'Central Nervous System Neoplasm', 'Glioblastoma', 'Gliosarcoma', 'Spinal Cord Neoplasm']}, 'referencesModule': {'references': [{'pmid': '20607350', 'type': 'BACKGROUND', 'citation': "Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4."}, {'pmid': '20589656', 'type': 'BACKGROUND', 'citation': "Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634."}, {'pmid': '20725730', 'type': 'RESULT', 'citation': "Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Holmes EJ, Zhou T, Jakacki RI; Children's Oncology Group. IDH1 mutations are common in malignant gliomas arising in adolescents: a report from the Children's Oncology Group. Childs Nerv Syst. 2011 Jan;27(1):87-94. doi: 10.1007/s00381-010-1264-1. Epub 2010 Aug 20."}]}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls.\n\nII. Determine the toxicity of this regimen in these patients. III. Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen.\n\nIV. Correlate polymorphisms in GSTP1, GSTM1 and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen.\n\nOUTLINE: This is a pilot, multicenter study.\n\nCHEMORADIOTHERAPY: Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47.\n\nMAINTENANCE CHEMOTHERAPY: Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year, every 6 months for 3 years and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:\n\n * Anaplastic astrocytoma\n * Glioblastoma multiforme\n * Gliosarcoma\n* Primary spinal cord malignant gliomas allowed\n* No primary brainstem tumors\n* Has undergone surgical resection or biopsy of the tumor within the past 31 days\n\n * Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries\n\n * Post-operative MRI not required for patients who undergo biopsy only\n* No evidence of neuraxis dissemination\n\n * Spine MRI and cerebrospinal fluid cytology required only if clinically indicated\n* Performance status - Karnofsky 50-100% (for patients \\> 16 years of age)\n* Performance status - Lansky 50-100% (for patients ≤ 16 years of age)\n* At least 8 weeks\n* Absolute neutrophil count ≥ 1,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3 (transfusion independent)\n* Hemoglobin ≥ 8 g/dL (transfusions allowed)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT ≤ 2.5 times ULN\n* Albumin ≥ 2 g/dL\n* Creatinine ≤ 1.5 times ULN\n* Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal\n* No evidence of dyspnea at rest\n* No exercise intolerance\n* Pulse oximetry ≥ 94% (if determination is clinically indicated)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study participation\n* Able to swallow oral medication\n* Seizures allowed provided they are well controlled with anticonvulsants\n* No hypersensitivity to temozolomide\n* No prior biologic agents\n* No prior chemotherapy\n* Prior corticosteroids allowed\n* No concurrent corticosteroids as an antiemetic\n* Concurrent corticosteroids allowed only for treatment of increased intracranial pressure\n* No concurrent radiotherapy using cobalt-60\n* See Disease Characteristics\n* No other prior treatment\n* No concurrent phenobarbital or cimetidine\n* No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy'}, 'identificationModule': {'nctId': 'NCT00100802', 'briefTitle': 'Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma', 'orgStudyIdInfo': {'id': 'ACNS0423'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02645', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ACNS0423'}, {'id': 'CDR0000407744'}, {'id': 'COG-ACNS0423'}, {'id': 'ACNS0423', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ACNS0423', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (lomustine, temozolomide, radiation therapy)', 'description': 'Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47. Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (lomustine, temozolomide, radiation therapy)']}, {'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea', '1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-', 'Belustin', 'Belustine', 'CCNU', 'Cecenu', 'CeeNU', 'Chloroethylcyclohexylnitrosourea', 'Citostal', 'Gleostine', 'Lomeblastin', 'Lomustinum', 'Lucostin', 'Lucostine', "N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea", 'Prava', 'RB-1509', 'WR-139017'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (lomustine, temozolomide, radiation therapy)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Treatment (lomustine, temozolomide, radiation therapy)']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['CCRG-81045', 'Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-', 'M & B 39831', 'M and B 39831', 'Methazolastone', 'RP-46161', 'SCH 52365', 'Temcad', 'Temodal', 'Temodar', 'Temomedac', 'TMZ'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (lomustine, temozolomide, radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Regina I Jakacki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}