Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT00053794
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018234', 'term': 'Sarcoma, Alveolar Soft Part'}, {'id': 'D006394', 'term': 'Hemangiosarcoma'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D013584', 'term': 'Sarcoma, Synovial'}, {'id': 'D018203', 'term': 'Sarcoma, Endometrial Stromal'}, {'id': 'C562740', 'term': 'Hemangiopericytoma, Malignant'}, {'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'D018319', 'term': 'Neurofibrosarcoma'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D036821', 'term': 'Endometrial Stromal Tumors'}, {'id': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009217', 'term': 'Myosarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105905', 'term': 'perifosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2008-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09-18', 'type': 'ACTUAL'}}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adult alveolar soft-part sarcoma', 'adult angiosarcoma', 'adult fibrosarcoma', 'adult leiomyosarcoma', 'adult liposarcoma', 'adult synovial sarcoma', 'endometrial stromal sarcoma', 'uterine leiomyosarcoma', 'adult malignant hemangiopericytoma', 'stage III adult soft tissue sarcoma', 'stage III uterine sarcoma', 'stage IV uterine sarcoma', 'recurrent adult soft tissue sarcoma', 'recurrent uterine sarcoma', 'adult malignant fibrous histiocytoma', 'adult neurofibrosarcoma', 'adult rhabdomyosarcoma', 'stage IV adult soft tissue sarcoma'], 'conditions': ['Endometrial Cancer', 'Sarcoma']}, 'referencesModule': {'references': [{'pmid': '16528479', 'type': 'RESULT', 'citation': 'Knowling M, Blackstein M, Tozer R, Bramwell V, Dancey J, Dore N, Matthews S, Eisenhauer E. A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2006 Sep;24(5):435-9. doi: 10.1007/s10637-006-6406-7.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy 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 perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of perifosine, in terms of response rate and duration of response, in patients with untreated metastatic or locally advanced soft tissue sarcoma.\n* Determine the toxicity of this drug in these patients.\n* Determine the early progression rate in patients treated with this drug.\n\nOUTLINE: This is a non-randomized, non-blinded, multicenter study.\n\nPatients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course. For all subsequent courses, patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for 1 month. Patients with stable or responsive disease are followed every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic or locally advanced soft tissue sarcoma that is incurable by standard therapies, including any of the following types:\n\n * Uterine sarcomas\n\n * Mixed mesodermal\n * Leiomyosarcoma\n * Endometrial stromal sarcoma\n * Alveolar soft part sarcoma\n * Angiosarcoma/lymphangiosarcoma\n * Fibrosarcoma\n * Hemangiopericytoma\n * Leiomyosarcoma\n * Liposarcoma\n * Malignant fibrous histiocytoma\n * Neurogenic sarcoma\n * Pleomorphic rhabdomyosarcoma\n * Synovial sarcoma\n * Unclassifiable sarcoma\n * Undifferentiated sarcoma\n* Excluded diseases include the following:\n\n * Bone sarcomas (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma)\n * Embryonal rhabdomyosarcoma\n * Carcinosarcoma\n * Kaposi's sarcoma\n * Malignant mesothelioma\n * Neuroblastoma\n * Gastrointestinal stromal tumor\n* At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as:\n\n * At least 20 mm by x-ray or physical exam\n * At least 10 mm by spiral CT scan\n * At least 20 mm by non-spiral CT scan NOTE: Bone lesions are not considered measurable\n\nNOTE: Patients whose sole site of disease is within a previously irradiated area are allowed if there is evidence of progression or new lesions in the irradiated field\n\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* AST no greater than 2.5 times ULN\n\nRenal\n\n* Creatinine no greater than ULN\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine\n* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix\n* No active or ongoing infection\n* No psychiatric illness or social situation that would limit compliance with study requirements\n* No other concurrent uncontrolled illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior systemic chemotherapy for metastatic or locally advanced disease\n* At least 6 months since prior adjuvant chemotherapy\n* No other concurrent cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy)\n* No concurrent radiotherapy to the sole site of measurable disease or for progressively symptomatic disease\n\nSurgery\n\n* At least 4 weeks since prior major surgery\n\nOther\n\n* No other concurrent anticancer therapy or investigational agents"}, 'identificationModule': {'nctId': 'NCT00053794', 'briefTitle': 'Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'I155'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND155', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000269476', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'perifosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Elizabeth A. Eisenhauer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Centre of Southeastern Ontario at Kingston General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}