Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00005602
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C089876', 'term': 'RMP 7'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2000-05-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'description': 'A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['untreated childhood brain stem glioma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.\n\nPURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.\n* Determine the toxic effects of this treatment regimen in these patients.\n* Assess the response to radiotherapy in patients treated with this regimen.\n\nOUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.\n\nThe first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.\n\nPatients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Newly diagnosed diffuse, intrinsic brain stem gliomas\n* Measurable disease\n* No disseminated disease at sites other than brain stem\n* No neurofibromatosis\n* Treatment must begin within 31 days of diagnosis\n\n * Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 3 to 21\n\nPerformance status:\n\n* Karnofsky 50-100% (over 10 years of age)\n* Lansky 50-100% (10 years of age and under)\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications)\n\nRenal:\n\n* Creatinine less than ULN for age OR\n* Creatinine clearance or glomerular filtration rate greater than 80 mL/min\n\nOther:\n\n* No history of severe allergic reaction to any platinum-containing compound\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* No concurrent growth factors during therapy with carboplatin\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Prior corticosteroids for brain stem glioma are allowed\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Prior surgery for brain stem glioma is allowed\n\nOther\n\n* At least 24 hours since any of the following medications:\n\n * Vasodilating compounds\n * Angiotensin-converting enzyme inhibitors\n * Calcium channel blockers\n * Beta blockers\n* No other prior therapy for brain stem glioma'}, 'identificationModule': {'nctId': 'NCT00005602', 'briefTitle': 'Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas', 'orgStudyIdInfo': {'id': 'ADVL0012'}, 'secondaryIdInfos': [{'id': 'COG-ADVL0012', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CCG-ADVL0012', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'ALK-01-042'}, {'id': 'CCG-09802', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'CDR0000067715', 'type': 'OTHER', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days', 'interventionNames': ['Drug: carboplatin', 'Drug: cereport', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days', 'interventionNames': ['Drug: carboplatin', 'Drug: cereport', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days', 'interventionNames': ['Drug: carboplatin', 'Drug: cereport', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days', 'interventionNames': ['Drug: carboplatin', 'Drug: cereport', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin', 'CBDCA', 'NSC #241240'], 'armGroupLabels': ['Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days']}, {'name': 'cereport', 'type': 'DRUG', 'otherNames': ['labradimil', 'IND #60315'], 'armGroupLabels': ['Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days', 'Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-0700', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital at Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'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': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York - Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein Clinical Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center - Cincinnati", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97201-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Doernbecher Children's Hospital", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center - Seattle", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Roger J. Packer, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's National Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}