Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00053118
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2003-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D012175', 'term': 'Retinoblastoma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'C531673', 'term': 'Familial ependymoma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D020339', 'term': 'Optic Nerve Glioma'}, {'id': 'D018335', 'term': 'Rhabdoid Tumor'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D019574', 'term': 'Optic Nerve Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-25', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['childhood central nervous system germ cell tumor', 'childhood choroid plexus tumor', 'childhood craniopharyngioma', 'childhood grade I meningioma', 'childhood grade II meningioma', 'childhood grade III meningioma', 'recurrent childhood brain stem glioma', 'recurrent childhood cerebellar astrocytoma', 'recurrent childhood cerebral astrocytoma', 'recurrent childhood ependymoma', 'recurrent childhood medulloblastoma', 'recurrent childhood supratentorial primitive neuroectodermal tumor', 'recurrent neuroblastoma', 'recurrent retinoblastoma', 'childhood visual pathway and hypothalamic glioma', 'childhood atypical teratoid/rhabdoid tumor', 'primary central nervous system non-Hodgkin lymphoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Lymphoma', 'Neuroblastoma', 'Retinoblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies.\n* Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is dose-escalation study of carboplatin.\n\nPatients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5 apheresis sessions. If the target number of peripheral blood stem cells is not achieved, some patients receive G-CSF and undergo apheresis as above after a 2-week rest.\n\nAt least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1 hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61, and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed monthly for 1 year and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary central nervous system malignancy\n* Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and under at initial diagnosis\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 8 weeks\n\nHematopoietic\n\n* Absolute neutrophil count greater than 750/mm\\^3\n* WBC greater than 2,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect\n\nHepatic\n\n* Liver function tests less than 2 times normal OR\n* Absence of active hepatitis by liver biopsy\n* Bilirubin less than 1.5 mg/dL\n\nRenal\n\n* Glomerular filtration rate greater than 60 mL/min by radionucleotide assay\n\nCardiovascular\n\n* Ejection fraction at least 45%\n\nPulmonary\n\n* Clinically normal pulmonary function (patients 5 years of age and under)\n* FEV\\_1 and FVC at least 50% (patients over 5 years of age) OR\n* Arterial blood gas normal and DLCO greater than 50%\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No mucositis or mucosal infection\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 3 weeks since prior systemic cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 6 months since prior radiotherapy to the pelvis or spine\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00053118', 'briefTitle': 'Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies', 'orgStudyIdInfo': {'id': 'CDR0000269284'}, 'secondaryIdInfos': [{'id': 'RPCI-DS-00-03'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'description': 'IV'}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'IV'}, {'name': 'etoposide', 'type': 'DRUG', 'description': 'IV'}, {'name': 'bone marrow ablation with stem cell support', 'type': 'PROCEDURE', 'description': 'IV'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'description': 'IV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Barbara Jean Bambach, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Barbara Bambach, MD', 'oldOrganization': 'Roswell Park Cancer Institute'}}}}