Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00062205
Status:
COMPLETED
Last Update Posted:
2010-02-09
First Post:
2003-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, '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': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-05', 'studyFirstSubmitDate': '2003-06-05', 'studyFirstSubmitQcDate': '2003-06-05', 'lastUpdatePostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate as measured by RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival at 6 months'}]}, 'conditionsModule': {'keywords': ['recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.\n\nPURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the effectiveness of imatinib mesylate in patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.\n* Determine the toxic effects of this drug in these patients.\n* Determine the duration of disease-free and overall survival of patients treated with this drug.\n\nOUTLINE: This is an open-label study.\n\nPatients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days.\n\nPROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of Ewing's family of tumors OR desmoplastic small round-cell tumor\n* Must have immunohistochemical evidence of expression of greater than 2+/4+ for either Kit (CD117) or platelet-derived growth factor receptor -a or -b\n* No symptomatic brain metastases\n\n * Asymptomatic brain metastases are allowed provided patient is not on concurrent anticonvulsants or corticosteroids\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 16\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count greater than 1,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 9 g/dL\n\nHepatic\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* SGOT and SGPT less than 2.5 times ULN\n* No chronic active hepatitis\n* No cirrhosis\n* No other acute or known chronic liver disease\n\nRenal\n\n* Creatinine less than 1.5 times ULN\n\nCardiovascular\n\n* No concurrent poorly controlled or severe cardiovascular disease\n\nPulmonary\n\n* No concurrent poorly controlled or severe pulmonary disease\n\nOther\n\n* HIV negative\n* No concurrent poorly controlled or severe central nervous system disease\n* No other concurrent poorly controlled or severe nonmalignant disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 3 weeks since prior chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n\nSurgery\n\n* More than 2 weeks since prior major surgery\n\nOther\n\n* More than 28 days since prior investigational agents"}, 'identificationModule': {'nctId': 'NCT00062205', 'briefTitle': "Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor", 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': "Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors", 'orgStudyIdInfo': {'id': 'CDR0000304551'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-IRB-02008'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Warren Chow MD', 'oldOrganization': 'City of Hope Medical Center'}}}}