Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT00017316
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116890', 'term': 'Semaxinib'}, {'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': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-08', 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-06-11', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.', 'detailedDescription': 'OBJECTIVES:\n\nI. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.\n\nII. Determine the quantitative and qualitative toxic effects of this regimen in these patients.\n\nIII. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen.\n\nV. Assess disease-free survival at 6 months of patients treated with this regimen.\n\nOUTLINE:\n\nPatients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic melanoma\n* Bidimensionally measurable disease by MRI, CT scan, or chest x-ray\n* No active brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* More than 12 weeks\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 8.5 g/dL\n\nHepatic:\n\n* PT/PTT normal\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT/SGPT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No uncompensated coronary artery disease by electrocardiogram or physical exam\n* No myocardial infarction or severe or unstable angina within the past 6 months\n* No deep venous thrombosis within the past 3 months\n* No arterial thrombosis within the past 6 months\n\nPulmonary:\n\n* No pulmonary embolism within the past 6 months\n\nOther:\n\n* HIV negative\n* No active infection\n* No medical, psychological, or social problem that would preclude study participation\n* No history of gastrointestinal disorder that would interfere with absorption or swallowing of study medication\n* No emotional disorder or substance abuse\n* No diabetes mellitus with severe peripheral vascular disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No more than 1 prior biologic regimen\n* No concurrent biologic response modifiers\n* No concurrent hematopoietic growth factor support\n* Concurrent epoetin alfa allowed\n\nChemotherapy:\n\n* No concurrent cytotoxic agents\n\nEndocrine therapy:\n\n* No concurrent anticancer hormonal therapy except megestrol acetate for appetite stimulation\n\nRadiotherapy:\n\n* No prior large field radiotherapy to more than 20% total bone marrow\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 14 days since major surgery\n* No prior major upper gastrointestinal surgery\n\nOther:\n\n* No other concurrent investigational therapy'}, 'identificationModule': {'nctId': 'NCT00017316', 'briefTitle': 'Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000068677'}, 'secondaryIdInfos': [{'id': 'UTHSC-IDD-99-27'}, {'id': 'SACI-IDD-99-27'}, {'id': 'NCI-66'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: semaxanib', 'Drug: thalidomide']}], 'interventions': [{'name': 'semaxanib', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}, {'name': 'thalidomide', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78284-7811', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Eric K. Rowinsky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}