Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-11 @ 2:13 PM
Study NCT ID:
NCT00003461
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D003397', 'term': 'Craniopharyngioma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'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': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['localized resectable neuroblastoma', 'recurrent neuroblastoma', 'recurrent adult brain tumor', 'adult craniopharyngioma', 'adult medulloblastoma', 'adult meningioma', 'adult glioblastoma', 'adult oligodendroglioma', 'tumors metastatic to brain', 'adult anaplastic astrocytoma', 'adult mixed glioma', 'adult pineal parenchymal tumor', 'adult central nervous system germ cell tumor', 'adult grade III meningioma', 'adult pilocytic astrocytoma', 'adult giant cell glioblastoma', 'adult gliosarcoma', 'adult pineal gland astrocytoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Metastatic Cancer', 'Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.\n\nPURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.\n* Identify objective therapeutic responses of these patients to this treatment.\n\nOUTLINE: This is a dose escalation study.\n\nPatients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.\n\nCohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.\n\nPatients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.\n\nPROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor\n* Measurable disease by MRI or CT scan\n\n * Candidate for surgical resection\n * Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity\n* Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody\n* No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 50-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.5 mg/dL\n* Alkaline phosphatase less than 1.5 times normal\n* SGOT less than 1.5 times normal\n\nRenal:\n\n* Creatinine less than 1.2 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression\n\nEndocrine therapy:\n\n* Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week\n\nRadiotherapy:\n\n* At least 3 months since prior radiotherapy to site of measurable disease in the CNS\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003461', 'briefTitle': 'Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors', 'orgStudyIdInfo': {'id': '2237'}, 'secondaryIdInfos': [{'id': 'DUMC-2237-01-12R4'}, {'id': 'DUMC-0013-00-1R2'}, {'id': 'DUMC-0036-99-1R1'}, {'id': 'DUMC-060-98-1'}, {'id': 'DUMC-2237-00-12R3'}, {'id': 'DUMC-98007'}, {'id': 'NCI-5P50NS20023'}, {'id': 'NCI-G98-1462'}, {'id': 'CDR0000066493'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'surgical procedure', 'type': 'PROCEDURE'}, {'name': 'astatine At 211 monoclonal antibody 81C6', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Darell D. Bigner, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}