Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00003718
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D006394', 'term': 'Hemangiosarcoma'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D018319', 'term': 'Neurofibrosarcoma'}, {'id': 'D013584', 'term': 'Sarcoma, Synovial'}, {'id': 'C563195', 'term': 'Chondrosarcoma, Extraskeletal Myxoid'}, {'id': 'D018234', 'term': 'Sarcoma, Alveolar Soft Part'}, {'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'C562740', 'term': 'Hemangiopericytoma, Malignant'}, {'id': 'C535700', 'term': 'Malignant mesenchymal tumor'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'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': 'D051642', 'term': 'Histiocytoma'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D036821', 'term': 'Endometrial Stromal Tumors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-08', 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-13', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adult angiosarcoma', 'adult fibrosarcoma', 'adult leiomyosarcoma', 'adult liposarcoma', 'adult neurofibrosarcoma', 'adult synovial sarcoma', 'recurrent adult soft tissue sarcoma', 'adult extraskeletal chondrosarcoma', 'adult alveolar soft-part sarcoma', 'adult epithelioid sarcoma', 'adult malignant fibrous histiocytoma', 'adult malignant hemangiopericytoma', 'adult malignant mesenchymoma', 'adult rhabdomyosarcoma', 'stage IV uterine sarcoma', 'recurrent uterine sarcoma', 'uterine carcinosarcoma', 'uterine leiomyosarcoma', 'endometrial stromal sarcoma', 'ovarian sarcoma', 'stage IV adult soft tissue sarcoma'], 'conditions': ['Endometrial Cancer', 'Ovarian Cancer', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.', 'detailedDescription': 'OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.\n\nOUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.\n\nPROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination No CNS metastases No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier treatment allowed At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent epoetin alfa Chemotherapy: See Disease Characteristics Prior dacarbazine allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: No other concurrent investigational drugs"}, 'identificationModule': {'nctId': 'NCT00003718', 'briefTitle': 'Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas', 'orgStudyIdInfo': {'id': 'CDR0000066827'}, 'secondaryIdInfos': [{'id': 'CPMC-IRB-8358'}, {'id': 'NCI-V98-1510'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temozolomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert N. Taub, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Irving Comprehensive Cancer Center', 'class': 'OTHER'}}}}