Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00002705
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topotecan in Treating Children With Refractory Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-05', 'lastUpdateSubmitDate': '2013-01-31', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-06-30', 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent childhood acute lymphoblastic leukemia', 'recurrent childhood acute myeloid leukemia', 'relapsing chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '11896112', 'type': 'RESULT', 'citation': 'Furman WL, Stewart CF, Kirstein M, Kepner JL, Bernstein ML, Kung F, Vietti TJ, Steuber CP, Becton DL, Baruchel S, Pratt C. Protracted intermittent schedule of topotecan in children with refractory acute leukemia: a pediatric oncology group study. J Clin Oncol. 2002 Mar 15;20(6):1617-24. doi: 10.1200/JCO.2002.20.6.1617.'}]}, 'descriptionModule': {'briefSummary': 'Phase I trial to study the effectiveness of topotecan in treating children with refractory leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.', 'detailedDescription': 'OBJECTIVES:\n\nI. Describe the qualitative and quantitative toxic effects, including acute and chronic dose-limiting toxicity, cumulative toxicity, and time to recovery, in pediatric patients with refractory leukemia who are treated with a 30-minute daily infusion of topotecan (TOPO) for up to 12 consecutive days every 3 weeks.\n\nII. Estimate the maximum tolerated dose of TOPO that results in tolerable, predictable, and reversible toxicity.\n\nIII. Determine the precautions and supportive therapy that should be used and the clinical and laboratory studies needed to monitor or alter therapy to prevent unacceptable toxicity in these patients.\n\nIV. Observe any antileukemic effects that may occur during this phase I study in which duration of treatment is increased from 7 to 9 and then 12 days and TOPO doses are escalated.\n\nV. Determine the recommended phase II pediatric dose of TOPO. VI. Characterize the pharmacokinetic parameters of TOPO and evaluate changes in these parameters with the first and last doses to determine whether there is drug accumulation.\n\nVII. Correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity.\n\nOUTLINE:\n\nSingle-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists\n\nPATIENT CHARACTERISTICS:\n\n* Age: Under 21\n* Performance status: ECOG 0-2\n* Life expectancy: At least 8 weeks\n* Adequate platelet count and hemoglobin required (transfusion allowed)\n* Bilirubin no greater than 1.5 mg/dL\n* AST or ALT no greater than 2 times normal\n* Creatinine less than 1.5 mg/dL\n* Adequate nutritional status, e.g. higher than third percentile weight for height\n* Albumin at least 3 g/dL\n* No severe uncontrolled infection\n* No pregnant women\n* Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas)\n* Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation)\n* No concurrent anticancer therapy\n* No concurrent treatment studies'}, 'identificationModule': {'nctId': 'NCT00002705', 'briefTitle': 'Topotecan in Treating Children With Refractory Leukemia', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY', 'orgStudyIdInfo': {'id': 'NCI-2012-01833'}, 'secondaryIdInfos': [{'id': 'POG-9575'}, {'id': 'CDR0000064511', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.', 'interventionNames': ['Drug: topotecan hydrochloride']}], 'interventions': [{'name': 'topotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'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': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'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': '32610-100277', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital and Clinics, University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital - Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital, Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Oncology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Floating Hospital Infants and Children', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'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': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Memorial Mission Hospital', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '38105-2794', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Dallas Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235-9154', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Cancer Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78236-5300', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Military Pediatric Cancer and Blood Disorders Center', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}, {'zip': '78284-7811', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Midwest Children's Cancer Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico School of Medicine Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Clinique de Pediatrie', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Wayne Lee Furman, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}