Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 9:24 AM
Study NCT ID:
NCT00085059
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C089739', 'term': '4-boronophenylalanine-fructose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2004-06-10', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment'}], 'secondaryOutcomes': [{'measure': 'Overall survival as measured every 8 weeks at completion of study treatment'}, {'measure': 'Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment'}, {'measure': 'Time to local progression measured every 8 weeks after completion of study treatment'}, {'measure': 'Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment'}, {'measure': 'Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment'}]}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '16362787', 'type': 'BACKGROUND', 'citation': 'Wittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue.\n\nPURPOSE: This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma.\n* Determine the objective local response in patients treated with this regimen.\n\nSecondary\n\n* Determine the overall survival of patients treated with this regimen.\n* Determine the duration of local response and time to local progression in patients treated with this regimen.\n* Determine the dose-response relationship at the per-lesion level in patients treated with this regimen.\n* Determine the safety of this regimen in these patients.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is an open-label study.\n\nPatients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2.\n\nPatients are followed at 1 and 6 weeks and then every 8 weeks thereafter. In the event of disease progression, patients are followed every 3 months for survival.\n\nPROJECTED ACCRUAL: A total of 16-24 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed melanoma\n\n * Metastatic disease\n\n * Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities\n * Accessible lesion(s) for boron neutron capture therapy (BNCT)\n * No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT\n* Measurable disease by MRI within the past 4 weeks\n\n * Lesion(s) ≥ 10 mm in diameter\n* Indication for palliative radiotherapy that is intended to be delivered as BNCT\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Neutrophil count ≥ 2,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10 g/dL\n\nHepatic\n\n* Bilirubin ≤ 2.5 times upper limit of normal (ULN)\\*\n* Transaminases ≤ 2.5 times ULN\\*\n* Alkaline phosphatase ≤ 2.5 times ULN\\* NOTE: \\*Unless due to reversible reaction to antiseizure medication\n\nRenal\n\n* Creatinine ≤ 2.5 times ULN\n* Blood urea nitrogen ≤ 2.5 times ULN\n\nCardiovascular\n\n* No congestive heart failure\n* No newly diagnosed or unstable angina pectoris\n* No uncontrolled arrhythmias\n* No uncontrolled conduction defects\n* No recent coronary artery disease\n* No other severe heart disease\n\nPulmonary\n\n* No severe pulmonary disease, including severe obstructive or restrictive lung disease\n\nOther\n\n* No history of phenylketonuria\n* No severe gastrointestinal disease\n* No active peptic ulcer disease\n* No uncontrolled endocrine disease\n* No pre-existing serious mental or organic brain disease (e.g., epilepsy)\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance\n* Able to travel to the Netherlands via public transportation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunologic or biologic therapy\n* No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim \\[G-CSF\\])\n\nChemotherapy\n\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* No prior radiotherapy to site(s) proposed for study treatment\n* No other concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)\n* No other concurrent anticancer therapy\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00085059', 'briefTitle': 'Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA', 'orgStudyIdInfo': {'id': 'EORTC-11011'}, 'secondaryIdInfos': [{'id': 'EORTC-11011'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'boronophenylalanine-fructose complex', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Andrea Wittig', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaetsklinikum Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}