Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00006102
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2000-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
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': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D020339', 'term': 'Optic Nerve Glioma'}, {'id': 'C531673', 'term': 'Familial 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': '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': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093269', 'term': 'becatecarin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['childhood infratentorial ependymoma', 'recurrent childhood rhabdomyosarcoma', 'childhood supratentorial ependymoma', 'childhood craniopharyngioma', 'disseminated neuroblastoma', 'recurrent neuroblastoma', 'intraocular retinoblastoma', 'extraocular retinoblastoma', 'stage III childhood lymphoblastic lymphoma', 'stage IV childhood lymphoblastic lymphoma', 'recurrent childhood lymphoblastic lymphoma', 'childhood central nervous system germ cell tumor', 'unspecified childhood solid tumor, protocol specific', 'childhood high-grade cerebral astrocytoma', 'childhood oligodendroglioma', 'childhood choroid plexus tumor', 'childhood grade I meningioma', 'childhood grade II meningioma', 'childhood grade III meningioma', 'stage III childhood large cell lymphoma', 'stage IV childhood small noncleaved cell lymphoma', 'stage IV childhood large cell lymphoma', 'recurrent childhood small noncleaved cell lymphoma', 'recurrent childhood large cell lymphoma', 'recurrent childhood brain stem glioma', 'recurrent childhood supratentorial primitive neuroectodermal tumor', 'recurrent childhood cerebellar astrocytoma', 'recurrent childhood cerebral astrocytoma', 'recurrent childhood medulloblastoma', 'recurrent childhood visual pathway and hypothalamic glioma', 'previously treated childhood rhabdomyosarcoma', 'recurrent childhood ependymoma', 'recurrent retinoblastoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Lymphoma', 'Neuroblastoma', 'Retinoblastoma', 'Sarcoma', 'Unspecified Childhood Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '17610262', 'type': 'RESULT', 'citation': "Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):577-80. doi: 10.1002/pbc.21274."}]}, 'descriptionModule': {'briefSummary': "Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.", 'detailedDescription': "OBJECTIVES:\n\nI. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.\n\nII. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.\n\nIII. Determine the toxicity of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma \\[closed to accrual as of 5/19/03\\]/peripheral primative neuroectodermal tumor \\[PNET\\] vs osteosarcoma \\[closed to accrual as of 5/19/03\\] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).\n\nPatients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed solid tumors\n\n * Neuroblastoma\n * Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)\n * Osteosarcoma (closed to accrual as of 5/19/03)\n * Rhabdomyosarcoma\n * Other extracranial solid tumors\n * CNS/brain tumors:\n\n * Medulloblastoma/PNET\n * Ependymoma\n * Brainstem glioma\n * Other CNS tumors\n * Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR\n* Histologically or cytologically proven non-Hodgkin's lymphoma\n\n * Refractory to standard treatment and no curative therapy available\n* Measurable disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and under at time of original diagnosis\n\nPerformance status:\n\n* Karnofsky 50-100% in patients over 10 years of age\n* Lansky 50-100% in patients age 10 and under\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1,000/mm\\^3\n* Platelet count greater than 75,000/mm\\^3\n* Hemoglobin greater than 8.0 g/dL\n\nHepatic:\n\n* Bilirubin normal for age\n* SGPT less than 2.5 times upper limit of normal\n* Amylase normal\n* Lipase normal\n\nRenal:\n\n* Creatinine normal for age OR\n* Glomerular filtration rate at least 60 mL/min\n\nOther:\n\n* No concurrent uncontrolled infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Recovered from prior immunotherapy\n\nChemotherapy:\n\n* At least 6 weeks since prior nitrosourea and recovered\n* Recovered from any other prior chemotherapy\n* No more than two prior chemotherapy regimens\n\nEndocrine therapy:\n\n* CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry\n\nRadiotherapy:\n\n* At least 6 weeks since prior extended radiotherapy and recovered\n* No prior total body irradiation\n\nSurgery:\n\n* Prior radiosurgery allowed\n\nOther:\n\n* No concurrent use of the following foods or medications:\n\n * Grapefruit juice\n * Erythromycin\n * Azithromycin\n * Clarithromycin\n * Rifampin and analogues\n * Fluconazole\n * Ketoconazole\n * Itraconazole\n * Cimetidine\n * Cannabinoids (marijuana or dronabinol)\n * Leukotriene inhibitors (e.g., zafirlukast and zileuton)\n* No other concurrent anticancer or investigational agents"}, 'identificationModule': {'nctId': 'NCT00006102', 'briefTitle': "Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors', 'orgStudyIdInfo': {'id': 'NCI-2012-01851'}, 'secondaryIdInfos': [{'id': 'COG-P9963'}, {'id': 'CDR0000068111', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': "Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma \\[closed to accrual as of 5/19/03\\]/peripheral primative neuroectodermal tumor \\[PNET\\] vs osteosarcoma \\[closed to accrual as of 5/19/03\\] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).\n\nPatients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.", 'interventionNames': ['Drug: becatecarin']}], 'interventions': [{'name': 'becatecarin', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016-7710', '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', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90801-1428', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Jonathan Jaques Children's Cancer Center at Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'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': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609-1809', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'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': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center/Kaiser Foundation Hospital - 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