Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT00004868
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2000-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116890', 'term': 'Semaxinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2005-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2000-03-07', 'studyFirstSubmitQcDate': '2003-05-22', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09-15', 'type': 'ACTUAL'}}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult meningioma', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult mixed glioma', 'adult grade III meningioma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.\n\nPURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.', 'detailedDescription': 'OBJECTIVES: Phase I:\n\n* Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic drugs.\n* Determine the toxic effects (safety profile) of this drug in this patient population.\n* Characterize the pharmacokinetics of this drug in these patients.\n* Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo, including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.\n\nPhase II:\n\n* Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in patients with recurrent high-grade glioma.\n* Determine, further, the safety profile of the phase II dose of this drug in this patient population.\n* Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.\n\nOUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).\n\nPatients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.\n\nCohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined, additional patients are accrued to the phase II portion of the study. These patients receive SU5416 IV, as in the phase I portion, at the appropriate MTD established in phase I.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months. An additional 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this study within 6-8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven supratentorial malignant primary glioma, including:\n\n * Glioblastoma multiforme\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Anaplastic mixed oligoastrocytoma\n * Malignant astrocytoma not otherwise specified\n * Benign or malignant meningiomas, including brain and spinal meningiomas\n* Patients with meningiomas are excluded from phase II portion of study\n* Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI\n* Must have failed prior radiotherapy\n* Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days\n\n * Must be on stable (unchanged) dose of steroids for at least 5 days before scans\n* Phase II:\n\n * Must have completed radiotherapy at least 2 months prior to enrollment\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* More than 8 weeks\n\nHematopoietic:\n\n* WBC at least 2,300/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 8 g/dL (transfusion allowed)\n\nHepatic:\n\n* SGOT less than 2.5 times upper limit of normal\n* Bilirubin normal\n* No significant active hepatic disease\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n* No significant active renal disease\n\nCardiovascular:\n\n* No uncompensated coronary artery disease on ECG or physical examination\n* No history of myocardial infarction or severe/unstable angina within the past 6 months\n* No deep venous or arterial thrombosis within the past 3 months\n\nPulmonary:\n\n* No pulmonary embolism within the past 3 months\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 2 months after study\n* No other serious concurrent illness\n* No significant active psychiatric disease\n* No diabetes mellitus with severe peripheral vascular disease\n* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No serious active infection\n* No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* Phase I:\n\n * No more than 2 prior chemotherapy regimens for recurrent disease\n* Phase II:\n\n * No more than 1 prior chemotherapy regimen for recurrent disease\n* At least 2 weeks since prior vincristine\n* At least 6 weeks since prior nitrosoureas\n* At least 3 weeks since prior procarbazine\n* Recovered from prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No concurrent radiotherapy\n\nSurgery:\n\n* Recovered from prior surgery\n* Recent prior resection of recurrent or progressive tumor allowed\n\nOther:\n\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00004868', 'briefTitle': 'SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy', 'nctIdAliases': ['NCT00006067'], 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas', 'orgStudyIdInfo': {'id': 'NABTC-9902'}, 'secondaryIdInfos': [{'id': 'CDR0000067527', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'MSKCC-01045'}, {'id': 'NCI-00-C-0173'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'semaxanib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Cancer Center and Cancer Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Neuro-Oncology Branch', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0752', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'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': '15213-3489', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235-9154', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Cancer Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'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': '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}}, {'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': 'Howard A. Fine, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Neuro-Oncology Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}