Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT00036894
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CC-5013 in Treating Patients With Recurrent Glioma
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': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'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': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077269', 'term': 'Lenalidomide'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-11', 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2002-05-13', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult mixed glioma', 'adult ependymoblastoma', 'adult anaplastic ependymoma', 'adult myxopapillary ependymoma', 'adult meningioma', 'adult meningeal hemangiopericytoma', 'adult brain stem glioma', 'adult grade III meningioma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '18056189', 'type': 'RESULT', 'citation': 'Fine HA, Kim L, Albert PS, Duic JP, Ma H, Zhang W, Tohnya T, Figg WD, Royce C. A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors. Clin Cancer Res. 2007 Dec 1;13(23):7101-6. doi: 10.1158/1078-0432.CCR-07-1546.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor.\n\nPURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.\n* Determine the toxic effects of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n* Determine the antiangiogenic activity of this drug in these patients.\n\nOUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no).\n\nPatients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed at 2 weeks.\n\nPROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* One of the following:\n\n * Histologically confirmed high-grade glioma\n\n * Glioblastoma multiforme\n * Gliosarcoma\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n * Anaplastic mixed oligoastrocytoma\n * Malignant glioma/astrocytoma, not otherwise specified\n * Meningioma\n * Hemangioblastoma\n * Ependymoma\n * Primitive neuroectodermal tumors\n * Hemangiopericytoma\n * Progressive glioma\n * Clinically and radiographically diagnosed brain stem glioma\n* Progressive or recurrent disease as determined by CT scan or MRI\n\n * Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor\n* Must have failed prior radiotherapy\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 90,000/mm\\^3\n* Hemoglobin at least 8 g/dL (transfusions allowed)\n\nHepatic:\n\n* Bilirubin less than 3 times upper limit of normal (ULN)\n* SGOT less than 3 times ULN\n* No significant active hepatic disease\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n* No significant active renal disease\n\nCardiovascular:\n\n* No significant active cardiac disease\n\nOther:\n\n* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No significant active psychiatric disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 2 weeks since prior interferon\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* At least 6 weeks since prior nitrosoureas\n* At least 4 weeks since prior temozolomide or carboplatin\n* At least 3 weeks since prior procarbazine\n* At least 2 weeks since prior vincristine\n* At least 4 weeks since other prior cytotoxic chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* At least 2 weeks since prior tamoxifen\n* Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 2 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* At least 2 weeks since prior tumor resection\n\nOther:\n\n* At least 2 weeks since other prior noncytotoxic agents\n* Concurrent enzyme-inducing antiepileptic drugs allowed\n* No concurrent rifampin\n* No concurrent grapefruit juice\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00036894', 'briefTitle': 'CC-5013 in Treating Patients With Recurrent Glioma', 'nctIdAliases': ['NCT00032214'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas', 'orgStudyIdInfo': {'id': 'CDR0000069338'}, 'secondaryIdInfos': [{'id': 'NCI-02-C-0145'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lenalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Howard A. Fine, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Neuro-Oncology Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}