Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT00025558
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2001-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'id': 'C531673', 'term': 'Familial ependymoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D004806', 'term': 'Ependymoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'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': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D013852', 'term': 'Thiotepa'}, {'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': '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'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013721', 'term': 'Triethylenephosphoramide'}, {'id': 'D001388', 'term': 'Aziridines'}, {'id': 'D001389', 'term': 'Azirines'}, {'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': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2011-03-25', 'studyFirstSubmitDate': '2001-10-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['childhood central nervous system germ cell tumor', 'recurrent adult brain tumor', 'adult medulloblastoma', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult mixed glioma', 'adult central nervous system germ cell tumor', 'adult pineoblastoma', 'recurrent childhood supratentorial primitive neuroectodermal tumor', 'recurrent childhood medulloblastoma', 'recurrent childhood ependymoma', 'adult giant cell glioblastoma', 'adult gliosarcoma', 'adult anaplastic ependymoma', 'adult supratentorial primitive neuroectodermal tumor (PNET)'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow 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 temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation.\n\nOUTLINE: This is a dose-escalation study of temozolomide.\n\nPatients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 3 consecutive days. After the third dose of G-CSF, patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not have adequate PBSC may undergo bone marrow harvest.\n\nPatients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3.\n\nPBSC or bone marrow are reinfused on day 0. Beginning on day 1, patients receive G-CSF SC or IV until blood counts recover.\n\nCohorts of 3-6 patients receive escalating doses of temozolomide 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 at day 42, at 3 months, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of one of the following malignant brain tumors:\n\n * Anaplastic astrocytoma\n * Glioblastoma multiforme\n * Anaplastic oligodendroglioma\n * Medulloblastoma\n * High-grade ependymoma\n * Germ cell tumors\n * Pineoblastoma\n * Other primitive neuroectodermal tumors\n* Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy)\n\n * No prior myeloablative doses of thiotepa OR\n* Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy\n\n * Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 1 to under 50\n\nPerformance status:\n\n* Karnofsky 70-100% OR\n* Lansky 70-100%\n\nLife expectancy:\n\n* More than 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n* Hemoglobin at least 10 g/dL (transfusion allowed)\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* SGOT/SGPT less than 2.5 times ULN\n* Alkaline phosphatase less than 2.5 times ULN\n\nRenal:\n\n* Creatinine less than 1.5 times ULN\n* Creatinine clearance at least 70 mL/min\n* BUN less than 1.5 times ULN\n\nCardiovascular:\n\n* Ejection fraction greater than 50% OR\n* Shortening fraction greater than 27%\n* No evidence of myocardial ischemia on EKG if over 40 years of age\n\nOther:\n\n* HIV negative\n* No AIDS-related illness\n* No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction)\n* No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 2 weeks since prior biologic therapy or immunotherapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 6 weeks since prior radiotherapy and recovered\n* At least 6 weeks since prior brachytherapy or radiosurgery\n\nSurgery:\n\n* See Disease Characteristics\n* Recovered from prior major surgery'}, 'identificationModule': {'nctId': 'NCT00025558', 'briefTitle': 'Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease', 'orgStudyIdInfo': {'id': 'CDR0000068973'}, 'secondaryIdInfos': [{'id': 'P30CA016087', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016087', 'type': 'NIH'}, {'id': 'NYU-0006H'}, {'id': 'NCI-G01-2022'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'temozolomide', 'type': 'DRUG'}, {'name': 'thiotepa', 'type': 'DRUG'}, {'name': 'autologous bone marrow transplantation', 'type': 'PROCEDURE'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Cancer Institute at New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43205-2696', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Columbus Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '6001', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Sharon L. Gardner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}