Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT00030667
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2002-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058405', 'term': 'Desmoplastic Small Round Cell Tumor'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'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': 'D018213', 'term': 'Neoplasms, Bone Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2002-02-14', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate, determined using the RECIST criteria', 'timeFrame': 'Up to 2 years', 'description': '95% confidence interval will be computed.'}, {'measure': 'Toxicity reported using the CTC version 2.0', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression', 'timeFrame': 'Up to 2 years', 'description': 'Calculated by the method of Kaplan and Meier.'}]}, 'conditionsModule': {'conditions': ['Childhood Desmoplastic Small Round Cell Tumor', 'Childhood Synovial Sarcoma', 'Gastrointestinal Stromal Tumor', 'Lung Metastases', 'Recurrent Childhood Soft Tissue Sarcoma', 'Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor', 'Recurrent Neuroblastoma', 'Recurrent Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.', 'detailedDescription': "OBJECTIVES:\n\nI. Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate.\n\nII. Determine the toxicity of this drug in these patients. III. Determine the time to progression in patients treated with this drug. IV. Determine the pharmacokinetics of this drug in these patients. V. Correlate response with c-kit and platelet-derived growth factor receptor expression in patients treated with this drug.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/primitive neuroectodermal tumor vs osteosarcoma vs neuroblastoma vs other).\n\nPatients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed solid tumors including the following:\n\n * Ewing's sarcoma\n * Bone or soft tissue primitive neuroectodermal tumor\n * Osteosarcoma\n * Neuroblastoma\n * Desmoplastic small round cell tumor\n * Synovial cell sarcoma\n * Gastrointestinal stromal tumor (GIST)\n* Metastatic pulmonary disease eligible\n\n * No pleural effusion of any size or definite radiologic evidence of pleural-based disease\n* Recurrent or refractory to conventional therapy\n\n * GIST eligible at initial presentation\n* Tumor tissue blocks must be available\n* At least 1 measurable lesion\n\n * At least 20 mm by conventional techniques\n * At least 10 mm by spiral CT scan\n * Lesions assessable only by radionuclide scan are not considered measurable\n* Performance status - Lansky 50-100% (≤ 10 years of age)\n* Performance status - Karnofsky 50-100% (\\> 10 years of age)\n* At least 2 months\n* Absolute neutrophil count ≥ 1,000/mm\\^3\\*\n* Platelet count ≥ 75,000/mm\\^3\\* (transfusion independent)\n* Hemoglobin ≥ 8.0 g/dL\\* (RBC transfusions allowed)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT ≤ 2.5 times ULN\n* INR \\< 1.5\n* PTT ≤ ULN\n* Fibrinogen ≥ lower limit of normal\n* Creatinine normal for age\n* Glomerular filtration rate ≥ 70 mL/min\n* No uncontrolled infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* At least 1 week since prior biologic therapy or immunotherapy and recovered\n* At least 1 week since prior growth factors\n* No concurrent immunomodulating agents\n* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered\n* No concurrent chemotherapy\n* No concurrent steroids\n* Recovered from prior radiotherapy\n* At least 2 weeks since prior local palliative radiotherapy (small port)\n* At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis\n* At least 6 weeks since other prior substantial bone marrow radiation\n* No concurrent radiotherapy during first course of treatment\n* Concurrent palliative radiotherapy to local painful lesions allowed after first course of treatment provided there is no evidence of disease progression and at least 1 measurable lesion remains outside radiation port\n* No concurrent therapeutic doses of warfarin\n* No concurrent anticonvulsants that induce the cytochrome p450 enzyme system (e.g., phenytoin, carbamazepine, and phenobarbital)\n* Concurrent benzodiazepines and gabapentin allowed\n* Concurrent low-molecular weight heparin allowed"}, 'identificationModule': {'nctId': 'NCT00030667', 'briefTitle': 'Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors', 'orgStudyIdInfo': {'id': 'NCI-2012-01869'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01869', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000069187'}, {'id': 'COG-ADVL0122'}, {'id': 'ADVL0122', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ADVL0122', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (imatinib mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: imatinib mesylate', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG', 'otherNames': ['CGP 57148', 'Gleevec', 'Glivec'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (imatinib mesylate)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (imatinib mesylate)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (imatinib mesylate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006-3776', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}], 'overallOfficials': [{'name': 'Mason Bond', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}