Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00281905
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1992-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2006-01-24', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Event-free survival'}, {'measure': 'Local recurrence or occurrence of CNS metastases'}, {'measure': 'Quality of survival'}, {'measure': 'Tolerance'}, {'measure': 'Long-term toxicity'}, {'measure': 'Proportion of patients requiring radiotherapy'}, {'measure': 'Prognosis of children who receive both chemotherapy and radiotherapy'}, {'measure': 'Nature and behavior of brain tumors'}]}, 'conditionsModule': {'keywords': ['untreated childhood brain stem glioma', 'childhood high-grade cerebral astrocytoma', 'childhood low-grade cerebral astrocytoma', 'untreated childhood cerebellar astrocytoma', 'childhood choroid plexus tumor', 'childhood infratentorial ependymoma', 'childhood supratentorial ependymoma', 'newly diagnosed childhood ependymoma', 'untreated childhood medulloblastoma', 'childhood oligodendroglioma', 'untreated childhood supratentorial primitive neuroectodermal tumor', 'disseminated neuroblastoma', 'localized resectable neuroblastoma', 'localized unresectable neuroblastoma', 'regional neuroblastoma', 'stage 4S neuroblastoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any remaining tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.', 'detailedDescription': "OBJECTIVES:\n\n* Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.\n* Determine the event-free survival and overall survival in children treated with this regimen.\n* Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.\n* Determine the quality of life in children treated with this regimen.\n* Determine the tolerability and long-term toxicity of this regimen in these children.\n* Determine the proportion of children who require radiotherapy after treatment with this regimen.\n* Determine the prognosis of children who receive both chemotherapy and radiotherapy.\n* Determine the nature and behavior of brain tumors in very young children.\n\nOUTLINE: This is a multicenter study.\n\n* Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.\n* Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.\n* Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.\n\nQuality of life is assessed periodically.\n\nAfter completion of study treatment, patients are followed periodically for at least 2 years.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of 1 of the following:\n\n * Brain stem tumor (histological confirmation not required)\n * Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:\n\n * Anaplastic (malignant) astrocytoma\n * Glioblastoma\n * Anaplastic (malignant) oligodendroglioma\n * Ependymoma\n * Anaplastic (malignant) ependymoma\n * Anaplastic (malignant) oligoastrocytoma\n * Choroid plexus carcinoma\n * Astroblastoma\n * Polar spongioblastoma\n * Gliomatosis cerebri\n * Anaplastic (malignant) ganglioglioma\n * Pineoblastoma\n * Mixed pineocytoma or pineoblastoma\n * Medulloepithelioma\n * Neuroblastoma\n * Ependymoblastoma\n * Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs\n* Has undergone surgery or biopsy of the tumor within the past 2-4 weeks\n\nPATIENT CHARACTERISTICS:\n\n* No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy\n* Prior steroids allowed\n* No concurrent steroids as anti-emetics\n\n * Concurrent steroids allowed for control of tumor-related symptoms'}, 'identificationModule': {'nctId': 'NCT00281905', 'briefTitle': 'Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Management of Children Aged Less Than 3 Years With Brain Tumors', 'orgStudyIdInfo': {'id': 'CDR0000454575'}, 'secondaryIdInfos': [{'id': 'CCLG-CNS-9204'}, {'id': 'EU-20574'}, {'id': 'CCLG-CNS-1992-04'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'methotrexate', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Our Lady's Hospital for Sick Children", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Institute of Child Health at University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': "Royal Liverpool Children's Hospital, Alder Hey", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M27 4HA', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': "Central Manchester and Manchester Children's University Hospitals NHS Trust", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sir James Spence Institute of Child Health', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': '0X3 9DU', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': "Children's Hospital - Sheffield", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'BT12 6BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Royal Belfast Hospital for Sick Children', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZG', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': "Royal Aberdeen Children's Hospital", 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'EH9 1LF', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Childrens Hospital for Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Richard Grundy, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Queen's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer and Leukaemia Group", 'class': 'OTHER'}}}}