Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT00006005
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Patients With Gynecologic Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018203', 'term': 'Sarcoma, Endometrial Stromal'}], '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': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D036821', 'term': 'Endometrial Stromal Tumors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-08', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2000-07-05', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I uterine sarcoma', 'stage II uterine sarcoma', 'stage III uterine sarcoma', 'stage IV uterine sarcoma', 'recurrent uterine sarcoma', 'uterine carcinosarcoma', 'uterine leiomyosarcoma', 'endometrial stromal sarcoma'], 'conditions': ['Endometrial Cancer', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.\n\nPURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.\n* Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.\n* Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.\n\nOUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy\n* Measurable disease\n\n * Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan\n * Histologically or cytologically confirmed neoplastic nature if solitary lesion\n * No nonmeasurable disease, defined as:\n\n * Bone lesions\n * Leptomeningeal disease\n * Ascites\n * Pleural/pericardial effusion\n * Inflammatory breast disease\n * Lymphangitis cutis/pulmonis\n * Unconfirmed abdominal masses not followed by imaging techniques\n * Cystic lesions\n* Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy\n* Postmenopausal or status post hysterectomy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Granulocyte count at least 1,000/mm\\^3\n* Platelet count at least 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin normal\n* Transaminases less than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL\n\nOther:\n\n* No grade 2 or greater peripheral neuropathy\n* No medical or social factors that would preclude study, including inability to take oral medication\n* No other serious illness requiring immediate therapy\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug'}, 'identificationModule': {'nctId': 'NCT00006005', 'briefTitle': 'Thalidomide in Treating Patients With Gynecologic Sarcomas', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin', 'orgStudyIdInfo': {'id': 'CDR0000068013'}, 'secondaryIdInfos': [{'id': 'NYGOG-99-001'}, {'id': 'NCI-314'}, {'id': 'NYOG-0102-073'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Cancer Center of Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Comprehensive Cancer Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "NYU School of Medicine's Kaplan Comprehensive Cancer Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's-Roosevelt Hospital Center - Roosevelt Division", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Weill Cornell Cancer Center at Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein Clinical Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Scott Wadler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}