Viewing Study NCT00028795


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Study NCT ID: NCT00028795
Status: COMPLETED
Last Update Posted: 2014-02-21
First Post: 2002-01-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2002-01-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved outcome'}, {'measure': 'Toxicity as assessed by NCI CTCAE v. 2.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['childhood brain stem glioma', 'childhood high-grade cerebral astrocytoma', 'childhood spinal cord neoplasm', 'untreated childhood brain stem glioma'], 'conditions': ['Brain and Central Nervous System Tumors']}, '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': '21345842', 'type': 'RESULT', 'citation': "Cohen KJ, Heideman RL, Zhou T, Holmes EJ, Lavey RS, Bouffet E, Pollack IF. Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group. Neuro Oncol. 2011 Apr;13(4):410-6. doi: 10.1093/neuonc/noq205. Epub 2011 Feb 22."}, {'pmid': '21339192', 'type': 'RESULT', 'citation': "Cohen KJ, Pollack IF, Zhou T, Buxton A, Holmes EJ, Burger PC, Brat DJ, Rosenblum MK, Hamilton RL, Lavey RS, Heideman RL. Temozolomide in the treatment of high-grade gliomas in children: a report from the Children's Oncology Group. Neuro Oncol. 2011 Mar;13(3):317-23. doi: 10.1093/neuonc/noq191."}, {'pmid': '17705175', 'type': 'RESULT', 'citation': "Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.', 'detailedDescription': "OBJECTIVES:\n\n* Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies.\n* Determine the toxicity of this regimen in these patients.\n* Determine the efficacy of this regimen in patients with DIPG.\n* Determine the toxicity of this regimen in patients with DIPG.\n\nOUTLINE: This is a multicenter study.\n\n* Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis\\*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.\n* Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity.\n\nNOTE: \\*For patients with diffuse intrinsic pontine glioma only\n\nPatients are followed every 3-6 months for 4 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed newly diagnosed CNS tumor of the following types:\n\n * High grade glioma (HGG) of one of the following histologies:\n\n * Anaplastic astrocytoma (grade III)\n * Glioblastoma multiforme (grade IV)\n * Gliosarcoma\n * Primary spinal cord malignant glioma\n * Diffuse intrinsic pontine glioma (DIPG)\n\n * Diagnosed by gadolinium-enhanced MRI\n * At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons\n * No diffuse leptomeningeal disease\n * No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:\n\n * Dorsally exophytic brainstem glioma\n * Cervico-medullary junction tumor\n * Focal low-grade glioma of the midbrain or brainstem\n * No diffuse brainstem enlargement due to neurofibromatosis\n* No primary brain stem malignant glioma\n* No M+ disease (CSF positive for tumor or metastatic disease)\n* Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 3 to 21\n\nPerformance status:\n\n* Karnofsky 50-100% OR\n* Lansky 50-100%\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\\*\n* Hemoglobin at least 10.0 g/dL\\* NOTE: \\*Transfusion independent\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT or SGPT less than 2.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nOther:\n\n* No other concurrent malignancy\n* Concurrent seizure disorder allowed if well controlled on anticonvulsants\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after completion of study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic:\n\n* No concurrent routine cytokine support\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No prior therapy for HGG or DIPG'}, 'identificationModule': {'nctId': 'NCT00028795', 'briefTitle': 'Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma', 'orgStudyIdInfo': {'id': 'ACNS0126'}, 'secondaryIdInfos': [{'id': 'COG-ACNS0126', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000069135', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemoradiotherapy', 'interventionNames': ['Drug: temozolomide', 'Procedure: adjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'temozolomide', 'type': 'DRUG', 'armGroupLabels': ['Chemoradiotherapy']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Chemoradiotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Cancer Research Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical 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Luke's Medical Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06360-7106', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06520-8064', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Comprehensive Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward General Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Hospital of Southwest Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0296', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': "Joe DiMaggio Children's Hospital at Memorial", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176-2197', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist-South Miami Regional Cancer Program', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic-Orlando", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': "Sacred Heart Children's Hospital", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33677-4227', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Children's Hospital of Tampa", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Kaplan Cancer Center at St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912-4000', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP-Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical Center of Central Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Cancer Research Center of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96859-5000', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center', 'geoPoint': 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