Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 10:25 AM
Study NCT ID:
NCT01743950
Status:
TERMINATED
Last Update Posted:
2025-01-08
First Post:
2012-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069475', 'term': 'Re-Irradiation'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019233', 'term': 'Retreatment'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'end of study, which will be an average of 12 months', 'description': 'time of first dose of PDRD+ Bevacizumab until time of death'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'up to 30 days post last dose of bevacizumab', 'description': 'time of first dose of PDRD+ Bevacizumab until time of death. All changes from baseline assessment will be recorded until 30 days post last dose of bevacizumab, assessed using the NCI CTCAE version 4.0 criteria.'}, {'measure': 'Incidence of Late Toxicities', 'timeFrame': 'from 90 days post radiotherapy until time of death', 'description': 'Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.'}, {'measure': 'progression free survival', 'timeFrame': 'at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients', 'description': 'Progression free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of disease progression or death.'}, {'measure': 'Change in Mini Mental State Exam (MMSE) Score', 'timeFrame': 'baseline and then approximately every 8 weeks for 18 months', 'description': 'The MMSE survey is a clinician facilitated instrument scored on a scale of 0-30 where scores of 0-17 indicate severe cognitive impairment, 18-23 indicate mild cognitive impairment, and 24-30 indicate no cognitive impairment.'}, {'measure': 'Change in Participant Reported FACT-BR Score', 'timeFrame': 'baseline and then approximately every 8 weeks for 18 months', 'description': "The Functional Assessment of Cancer Therapy - Brain (FACT-BR) instrument is a 50-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is 0-200 where higher scores indicate higher quality of life."}, {'measure': 'Change in Participant Reported FACIT-F Score', 'timeFrame': 'baseline and then approximately every 8 weeks for 18 months', 'description': "The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) instrument is a 13-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is from 0-52 where higher scores indicate better quality of life. A score of less than 30 indicates severe fatigue."}, {'measure': 'Change in Karnofsky Performance Status', 'timeFrame': 'baseline and then approximately every 8 weeks for 18 months', 'description': "The Karnofsky Performance Status measures a cancer patient's ability to perform ordinary tasks. It is score from 0-100 where 0 means a person has died, less than 40 is various degrees of unable to care for oneself, 50-70 is unable to work but can care for personal needs with variable assistance, and 80-100 is able to carry on normal activity with variable symptoms of disease."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glioblastoma', 'anaplastic glioma'], 'conditions': ['Glioma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines\n* Recurrent disease based on combination of clinical, imaging or histologic confirmation\n* Must have previously received radiation and temozolomide to treat their glioma\n* Bevacizumab naive patients must be \\> 5 months post completion of initial radiation therapy\n* Bevacizumab exposed patients must be \\> 3 months post completion of initial radiation therapy\n* Age must be \\>18years, KPS must be greater than 60\n* Hematology, chemistry and a urinalysis must meet protocol specified criteria\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Uncontrolled hypertension (\\>160/90mmHg)\n* Prior malignancy unless treated \\>1 year prior to study and have been without treatment and disease free for 1 yr\n* active second malignancy unless non-melanoma skin cancer or cervical cancer in situ'}, 'identificationModule': {'nctId': 'NCT01743950', 'briefTitle': 'A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab', 'orgStudyIdInfo': {'id': 'CO11374'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02775', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': '2012-0648', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': '2017-0683', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A533300', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\HUMAN ONCOLOGY\\HUMAN ONCO', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 10/14/2020', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab-naïve with recurrent IDH wildtype high grade glioma', 'description': '27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression', 'interventionNames': ['Drug: Bevacizumab', 'Radiation: PRDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma', 'description': '27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression', 'interventionNames': ['Drug: Bevacizumab', 'Radiation: PRDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab-naïve with recurrent IDH mutant glioma', 'description': '27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression', 'interventionNames': ['Drug: Bevacizumab', 'Radiation: PRDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab-exposed with recurrent IDH mutant glioma', 'description': '27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression', 'interventionNames': ['Drug: Bevacizumab', 'Radiation: PRDR']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': '10mg/kg every 2weeks.', 'armGroupLabels': ['Bevacizumab-exposed with recurrent IDH mutant glioma', 'Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma', 'Bevacizumab-naïve with recurrent IDH mutant glioma', 'Bevacizumab-naïve with recurrent IDH wildtype high grade glioma']}, {'name': 'PRDR', 'type': 'RADIATION', 'otherNames': ['re-irradiation'], 'description': 'Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.', 'armGroupLabels': ['Bevacizumab-exposed with recurrent IDH mutant glioma', 'Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma', 'Bevacizumab-naïve with recurrent IDH mutant glioma', 'Bevacizumab-naïve with recurrent IDH wildtype high grade glioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Steve Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'H. Ian Robins, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}