Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT02068157
Status:
TERMINATED
Last Update Posted:
2017-10-11
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'C562489', 'term': 'Lymphoid Interstitial Pneumonia'}, {'id': 'D014062', 'term': 'Tongue Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'C008848', 'term': '1-phenyl-3,3-dimethyltriazene'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D017323', 'term': 'Dihematoporphyrin Ether'}, {'id': 'D014307', 'term': 'Trioxsalen'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D017324', 'term': 'Hematoporphyrin Derivative'}, {'id': 'D006415', 'term': 'Hematoporphyrins'}, {'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011564', 'term': 'Furocoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adrienne.Groman@RoswellPark.org', 'phone': '716-845-2300', 'title': 'Senior Administrator, Compliance - Clinical Research Services', 'organization': 'Roswell Park Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Porfimer Sodium, Image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPhotodynamic Therapy: Undergo image-guided I-PDT\n\nPorfimer Sodium: Given IV', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 36, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 35, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Porfimer Sodium, Image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPhotodynamic Therapy: Undergo image-guided I-PDT\n\nPorfimer Sodium: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated and eligible patients'}, {'type': 'SECONDARY', 'title': 'Serum Alkaline DNase (SADA) Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Porfimer Sodium, Image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPhotodynamic Therapy: Undergo image-guided I-PDT\n\nPorfimer Sodium: Given IV'}], 'timeFrame': 'Up to 12 months', 'description': 'SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.', 'reportingStatus': 'POSTED', 'populationDescription': 'The published assay could not be validated in murine samples. As such, no human samples were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Porfimer Sodium, Image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPhotodynamic Therapy: Undergo image-guided I-PDT\n\nPorfimer Sodium: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Porfimer Sodium, Image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPhotodynamic Therapy: Undergo image-guided I-PDT\n\nPorfimer Sodium: Given IV'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '14.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated and eligible patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study no longer has an active IDE', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2014-02-18', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-26', 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1', 'timeFrame': 'Up to 12 months', 'description': 'Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'Serum Alkaline DNase (SADA) Activity', 'timeFrame': 'Up to 12 months', 'description': 'SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Laryngeal Squamous Cell Carcinoma', 'Recurrent Laryngeal Verrucous Carcinoma', 'Recurrent Lip and Oral Cavity Squamous Cell Carcinoma', 'Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary', 'Recurrent Oral Cavity Verrucous Carcinoma', 'Recurrent Oropharyngeal Squamous Cell Carcinoma', 'Tongue Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.\n\nOUTLINE:\n\nPatients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.\n\nAfter completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\< 2\n* Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck\n* Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)\n* Patients on chemotherapy \\&/or targeted agents for palliation\n* Life expectancy of at least 6 months in the judgment of the physician\n* Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after the last treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Radiotherapy within the last 2 months in the area to be treated\n* Patients with known brain metastases should be excluded from this clinical trial\n* Tumor invading a major blood vessel (such as the carotid artery)\n* Tumor is not clearly shown on a computed tomography (CT) scan\n* Location and extension of the tumor precludes an effective I-PDT\n* Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds\n* While blood cell (WBC) \\< 2.0 x 10\\^9/L\n* Total serum bilirubin \\> 2.0 mg/dl\n* Serum creatinine \\> 2 mg/dl\n* Alkaline phosphatase (hepatic) \\> 3 times the upper normal limit\n* Serum glutamic oxaloacetic transaminase (SGOT) \\> 3 times the upper limit of normal\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or nursing female subjects\n* Unwilling or unable to follow protocol requirements and the light exposure precautions\n* Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy"}, 'identificationModule': {'nctId': 'NCT02068157', 'briefTitle': 'Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II', 'orgStudyIdInfo': {'id': 'I 235613'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00210', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 235613', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'P30CA016056', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016056', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (porfimer sodium, image-guided I-PDT)', 'description': 'Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Photodynamic Therapy', 'Drug: Porfimer Sodium']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (porfimer sodium, image-guided I-PDT)']}, {'name': 'Photodynamic Therapy', 'type': 'DRUG', 'otherNames': ['PDT', 'Photoradiation Therapy'], 'description': 'Undergo image-guided I-PDT', 'armGroupLabels': ['Treatment (porfimer sodium, image-guided I-PDT)']}, {'name': 'Porfimer Sodium', 'type': 'DRUG', 'otherNames': ['CL-184116', 'DHE', 'Dihematoporphyrin Ester', 'Dihematoporphyrin Ether', 'Photofrin II'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (porfimer sodium, image-guided I-PDT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Hassan Arshad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}