Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00064220
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2003-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D013584', 'term': 'Sarcoma, Synovial'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D006394', 'term': 'Hemangiosarcoma'}, {'id': 'C562740', 'term': 'Hemangiopericytoma, Malignant'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105791', 'term': 'soblidotin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adult leiomyosarcoma', 'adult malignant fibrous histiocytoma', 'adult liposarcoma', 'adult rhabdomyosarcoma', 'adult synovial sarcoma', 'adult fibrosarcoma', 'adult angiosarcoma', 'adult malignant hemangiopericytoma', 'stage IV adult soft tissue sarcoma', 'recurrent adult soft tissue sarcoma'], 'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '17109446', 'type': 'RESULT', 'citation': 'Patel S, Keohan ML, Saif MW, Rushing D, Baez L, Feit K, DeJager R, Anderson S. Phase II study of intravenous TZT-1027 in patients with advanced or metastatic soft-tissue sarcomas with prior exposure to anthracycline-based chemotherapy. Cancer. 2006 Dec 15;107(12):2881-7. doi: 10.1002/cncr.22334.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin.\n* Determine the duration of response in patients treated with this drug.\n* Determine the time to tumor progression in patients treated with this drug.\n* Determine the median survival time and 12-month survival rate of patients treated with this drug.\n* Determine the quantitative and qualitative toxic effects of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for survival.\n\nPROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:\n\n * Malignant fibrous histiocytoma\n * Liposarcoma\n * Rhabdomyosarcoma\n * Synovial sarcoma\n * Malignant paraganglioma\n * Fibrosarcoma\n * Leiomyosarcoma\n * Angiosarcoma, including hemangiopericytoma\n * Malignant peripheral nerve sheath tumor\n * Unclassified sarcoma\n * Miscellaneous sarcoma, including mixed mesodermal tumors of the uterus\n* The following tumor types are not eligible:\n\n * Gastrointestinal stromal tumor\n * Chondrosarcoma\n * Malignant mesothelioma\n * Neuroblastoma\n * Osteosarcoma\n * Ewing's sarcoma\n * Embryonal rhabdomyosarcoma\n* Evidence of disease progression\n* Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease\n\n * Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy\n* At least 1 measurable lesion with indicator lesions outside of any prior radiation field\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 15 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)\n* Bilirubin no greater than 1.5 times ULN\n\nRenal\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular\n\n* Ejection fraction at least 40% by MUGA\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No baseline neurotoxicity grade 2 or greater\n* No concurrent serious infection\n* No psychiatric disorder that would preclude giving informed consent or complying with study requirements\n* No other concurrent severe or uncontrolled medical illness that would preclude study participation\n* No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent anticancer biologic therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior chemotherapy and recovered\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* Recovered from prior radiotherapy\n* No concurrent radiotherapy\n\n * Localized radiotherapy to a non-indicator lesion for pain relief allowed provided all other methods of pain control are ineffective\n\nSurgery\n\n* At least 4 weeks since prior major surgery and recovered\n\nOther\n\n* At least 4 weeks since prior myelosuppressive therapy\n* At least 4 weeks since prior investigational drugs\n* No other concurrent investigational drugs\n* No other concurrent anticancer cytotoxic therapy"}, 'identificationModule': {'nctId': 'NCT00064220', 'briefTitle': 'Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'CDR0000310138'}, 'secondaryIdInfos': [{'id': 'DAIICHI-1027A-PRT007'}, {'id': 'CPMC-IRB-20030512'}, {'id': 'MSKCC-03061'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'soblidotin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '00927-5800', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Veterans Affairs Medical Center - San Juan', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Juan Pagan', 'role': 'STUDY_CHAIR', 'affiliation': 'Daiichi Sankyo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}