Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-29 @ 9:50 PM
Study NCT ID:
NCT00128635
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576180', 'term': '131I-chimeric TNT-1-B monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days'}, {'measure': 'Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks'}, {'measure': 'Overall survival, median time of survival, and percent alive at 6 months'}]}, 'conditionsModule': {'keywords': ['adult glioblastoma', 'adult gliosarcoma', 'adult giant cell glioblastoma', 'recurrent adult brain tumor'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (\\^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of \\^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.\n\nSecondary\n\n* Determine the biodistribution and radiation dosimetry of this drug in these patients.\n* Determine the toxicity and tolerability of this drug in these patients.\n* Determine the overall survival, median time of survival, and 6-month survival of patients treated with this drug.\n\nOUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of iodine I 131 monoclonal antibody TNT-1/B (\\^131I MOAB TNT-1/B).\n\nThe first 12 patients accrued to the study undergo stereotactic placement of 2 catheters within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of \\^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by dosimetry, biodistribution evaluations, and whole body imaging over an 8-10 day period. Beginning at least 2 weeks, but no more than 4 weeks later, all patients undergo catheter placement as above. One day later, patients receive a therapeutic dose of \\^131I MOAB TNT-1/B interstitially over approximately 25 hours.\n\nCohorts of 3-6 patients receive escalating therapeutic doses of \\^131I MOAB TNT-1/B 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. An additional 10 patients are treated at the MTD.\n\nAfter completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks, at 4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until disease progression, and then every 8 weeks thereafter.\n\nPROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed glioblastoma multiforme\n\n * Focal disease\n * Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy\n * Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed\n* Gross tumor volume 5-60 mL\n* No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles\n* No bilateral non-contiguous gadolinium-enhancing tumor\n* No diffuse disease, defined as any satellite lesion \\> 1.5 cm from the anticipated location of a catheter tip OR \\> 2 satellite lesions\n* No ventricular invasion outside the anticipated radiotherapy volume\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9.0 g/dL\n\nHepatic\n\n* Bilirubin ≤ 1.5 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal (ULN)\n* Hepatitis B negative\n* No evidence of active hepatitis\n\nRenal\n\n* Creatinine ≤ 1.7 mg/dL\n* BUN ≤ 2 times ULN\n\nCardiovascular\n\n* No uncontrolled hypertension\n* No unstable angina pectoris\n* No uncontrolled cardiac dysrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to undergo MRI\n* Mini Mental State Exam score ≥ 15\n* No serious infection\n* No other medical illness that would preclude study participation\n* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer\n* No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance\n* No known or suspected allergy to study drug or iodine\n* No known HIV positivity\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior monoclonal antibodies\n* No prior local immunotherapy or treatment with the following biologic agents:\n\n * Immunotoxins\n * Immunoconjugates\n * Antiangiogenesis compounds\n * Antisense agents\n * Peptide receptor antagonist\n * Interferons\n * Interleukins\n * Tumor infiltrating lymphocytes\n * Lymphokine-activated killer cells\n * Gene therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n* At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer\\^® )\n\nEndocrine therapy\n\n* Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 3 months since prior radiotherapy\n* No prior brachytherapy or radiosurgery\n\nSurgery\n\n* At least 4 weeks since prior surgery\n\nOther\n\n* Recovered from all prior therapy\n* At least 1 month since prior investigational agents\n* No more than 2 prior treatment regimens\n* No other prior local therapy'}, 'identificationModule': {'nctId': 'NCT00128635', 'briefTitle': 'Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse', 'orgStudyIdInfo': {'id': 'CDR0000438768'}, 'secondaryIdInfos': [{'id': 'NABTT-0404'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'iodine I 131 monoclonal antibody TNT-1/B', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '27157-1096', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Robert A. Lustig, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}, {'name': 'Kevin Judy, MD', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}