Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-27 @ 8:47 PM
Study NCT ID:
NCT00004068
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
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': '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-03', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-05-07', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['childhood high-grade cerebral astrocytoma', 'childhood high-grade cerebellar astrocytoma', 'childhood oligodendroglioma', 'untreated childhood brain stem glioma', 'untreated childhood cerebellar astrocytoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '16200343', 'type': 'RESULT', 'citation': 'Broniscer A, Chintagumpala M, Fouladi M, Krasin MJ, Kocak M, Bowers DC, Iacono LC, Merchant TE, Stewart CF, Houghton PJ, Kun LE, Ledet D, Gajjar A. Temozolomide after radiotherapy for newly diagnosed high-grade glioma and unfavorable low-grade glioma in children. J Neurooncol. 2006 Feb;76(3):313-9. doi: 10.1007/s11060-005-7409-5.'}, {'pmid': '15565574', 'type': 'RESULT', 'citation': 'Broniscer A, Iacono L, Chintagumpala M, Fouladi M, Wallace D, Bowers DC, Stewart C, Krasin MJ, Gajjar A. Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98). Cancer. 2005 Jan 1;103(1):133-9. doi: 10.1002/cncr.20741.'}, {'type': 'RESULT', 'citation': 'Broniscer A, Chintagumpala M, Bowers D, et al.: Upfront protracted irinotecan (CPT-11) followed by radiotherapy (RT) and temozolomide (TMZ) in the treatment of children with newly diagnosed high-grade glioma (HGG) and unfavorable low-grade glioma (LGG): results of a multi-institutional study (SJHG-98). [Abstract] Neuro-Oncology 6 (4): TP-01, 385, 2004.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, '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. Combining chemotherapy with radiation therapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor.', 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease, and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease.\n* Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide.\n* Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population.\n\nOUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan and if appropriate, patients may undergo a second surgical resection.\n\nWithin 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection, patients receive image guided external beam radiotherapy 5 days per week for 6 weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost radiosurgery.\n\nAt 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5 days. Treatment repeats every 3 weeks for 6 courses.\n\nPatients are followed every 3 months for 2 years, then every 4 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed newly diagnosed brain tumors\n\n * Grade III or IV disease:\n\n * Glioblastoma multiforme\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Anaplastic pleomorphic xanthoastrocytoma\n * Anaplastic or malignant oligoastrocytoma\n * Gemistocytic astrocytoma\n * Malignant glioma\n * Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement)\n * Diffuse pontine gliomas with greater than 2/3 involvement of the pon\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 3 to 21\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 2,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 8.0 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 2.5 mg/dL\n* SGOT/SGPT less than 5 times normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nOther:\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Prior corticosteroids allowed\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* No more than 28 days since prior definitive surgery for brain tumor\n\nOther:\n\n* Concurrent anticonvulsants allowed'}, 'identificationModule': {'nctId': 'NCT00004068', 'briefTitle': 'Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide', 'orgStudyIdInfo': {'id': 'CDR0000067271'}, 'secondaryIdInfos': [{'id': 'P30CA021765', 'link': 'https://reporter.nih.gov/quickSearch/P30CA021765', 'type': 'NIH'}, {'id': 'SJCRH: SJHG98'}, {'id': 'SPRI-P-00112'}, {'id': 'NCI-G99-1577'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG'}, {'name': 'temozolomide', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105-2794', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Amar Gajjar, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}