Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-08 @ 11:02 PM
Study NCT ID:
NCT03403634
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D007438', 'term': 'Introns'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'C047490', 'term': 'poly(I).poly(c12,U)'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kristopher.Attwood@Roswellpark.org', 'phone': '716-845-1300', 'title': 'Kris Attwood', 'organization': 'Roswell Park Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected up to 30 days after end of treatment, up to 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 8, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Gastrointestinal disorders **Any AE - Maximum Grade Seen Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neoplasm (NOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Tumor-infiltrating Lymphocytes (TILs) in the Colorectal Cancer Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '7.25', 'spread': '13.79', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000'], 'pValueComment': 'significance level = 0.05', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 12 months', 'description': 'The TILs will be summarized by time-point (pre-/post-treatment) using the mean, median, standard deviation; and graphically using dot-plots.\n\nThe TIL of interest is CD8a expression, which is reported as the mean fold change from pre-treatment (i.e. post treatment / pre treatment).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients did not have post treatment biopsies, and were considered unevaluable for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Indicated Grade Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'classes': [{'categories': [{'title': 'No Treatment Related AE Reported', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Grade I', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Grade IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade V', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Safety profile will be characterized by type, frequency, severity, timing, seriousness and relationship to study treatment. The highest grade treatment related AE is provided (per Common Terminology Criteria for Adverse Events version 4.0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that received study treatment.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': "Will be treated as binary data and summarized using frequencies and relative frequencies; with the ORR estimated using a 90% confidence interval obtained using Jeffrey's prior method.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluated in subjects evaluable for the primary end-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of treatment until disease progression (defined by RECIST 1.1) or last-follow-up, assessed up to 12 months', 'description': 'Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.', 'unitOfMeasure': 'Months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluated in subjects evaluable for the primary end-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '15.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of treatment until death due to any cause or last follow-up, assessed up to 12 months', 'description': 'Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.', 'unitOfMeasure': 'Months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluated in subjects evaluable for the primary end-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '19 patients were accrued and completed consent.', 'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Treated', 'achievements': [{'comment': '4 patients became ineligible prior to the start of treatment.', 'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nCelecoxib: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Interferon Alfa-2b: Given IV\n\nRintatolimod: Given IV'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', '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': '14', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Line of Treatment', 'classes': [{'categories': [{'title': 'Third Line', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Fourth Line', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Fifth or More Line', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'What line of treatment is the subject receiving 9i.e. number of prior lines + 1).', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Stage', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Stage II', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Stage III', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Stage IV', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed by American Joint Committee on Cancer (AJCC) cancer staging system, 7th edition. Clinical Staging determines how much cancer there is based on the physical examination, imaging tests, and biopsies of affected areas.\n\nStage I - lowest level of disease Stage IV - highest level of disease, with metastatic components', 'unitOfMeasure': 'Participants'}, {'title': 'Location of Disease', 'classes': [{'categories': [{'title': 'Cecum', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Colon, NOS', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Rectum, NOS', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Sigmoid Colon', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Radiation', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients that received radiation as a prior therapy.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Surgery', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients that had site specific surgery as part of a prior therapy.', 'unitOfMeasure': 'Participants'}, {'title': 'RAS Type', 'classes': [{'categories': [{'title': 'KRAS', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'NRAS', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Wild-type', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'RAS mutation type was assessed using tumor tissue, and identified as either: KRAS mutation, NRAS mutation, or Wildtype.\n\nthis was assessed as part of the inclusion criteria #3:\n\n"Prior treatment with, contra-indication to or refusal of a fluoropyrimidine, irinotecan, oxaliplatin and an anti-EGFR targeted therapy (if RAS wild type), as well as a PD-1 or PD-L1 targeted drug if MSI-H/dMMR."', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There were 19 patients accrued to the study; however, 4 never received any treatment and became ineligible.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-29', 'size': 656853, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-01T13:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2018-01-11', 'resultsFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-25', 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'From the start of treatment until disease progression (defined by RECIST 1.1) or last-follow-up, assessed up to 12 months', 'description': 'Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.'}, {'measure': 'Overall Survival', 'timeFrame': 'From the start of treatment until death due to any cause or last follow-up, assessed up to 12 months', 'description': 'Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.'}], 'primaryOutcomes': [{'measure': 'Change in Tumor-infiltrating Lymphocytes (TILs) in the Colorectal Cancer Lesions', 'timeFrame': 'Baseline up to 12 months', 'description': 'The TILs will be summarized by time-point (pre-/post-treatment) using the mean, median, standard deviation; and graphically using dot-plots.\n\nThe TIL of interest is CD8a expression, which is reported as the mean fold change from pre-treatment (i.e. post treatment / pre treatment).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Indicated Grade Adverse Event', 'timeFrame': 'Up to 12 months', 'description': 'Safety profile will be characterized by type, frequency, severity, timing, seriousness and relationship to study treatment. The highest grade treatment related AE is provided (per Common Terminology Criteria for Adverse Events version 4.0).'}, {'measure': 'Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1', 'timeFrame': 'Up to 12 months', 'description': "Will be treated as binary data and summarized using frequencies and relative frequencies; with the ORR estimated using a 90% confidence interval obtained using Jeffrey's prior method."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Carcinoma in the Liver', 'Recurrent Colorectal Carcinoma', 'Stage IV Colorectal Cancer AJCC v7', 'Stage IVA Colorectal Cancer AJCC v7', 'Stage IVB Colorectal Cancer AJCC v7']}, 'descriptionModule': {'briefSummary': "This early phase IIA trial studies how well celecoxib, recombinant interferon alfa-2b, and rintatolimod work in treating patients with colorectal cancer that as spread to the liver. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Rintatolimod may stimulate the immune system. Giving celecoxib, recombinant interferon alfa-2b, and rintatolimod may work better at treating colorectal cancer that has spread to the liver.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the impact of a chemokine-modulatory regimen on the immune microenvironment of colorectal liver metastases, specifically the changes in the ratio between cytotoxic T-lymphocyte (CTL) marker (CD8a gene expression) to regulatory T cell (Treg) markers (FoxP3 gene expression).\n\nSECONDARY OBJECTIVES:\n\nI. Estimate the objective response rate of a chemokine-modulatory regimen in metastatic colorectal cancer (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1).\n\nII. Examine the safety and tolerability profile of the combination of recombinant interferon alfa-2b (interferon alpha-2b), rintatolimod, and celecoxib when given as chemokine modulation to colorectal cancer patients prior to surgical resection using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).\n\nTERTIARY OBJECTIVES:\n\n* Estimate the median progression free survival of a chemokine-modulatory regimen in metastatic colorectal cancer\n* Estimate overall survival in participants with recurrent and/or metastatic unresectable colorectal cancer who received the chemokine-modulatory regimen\n* Comparison (using RT-PCR, immunofluorescence \\[IF\\] and immunohistochemistry \\[IHC\\] on serial sections) of the metastatic tissue specimen with regard to total numbers of infiltrating T cells, their CD4/CD8 ratios, frequencies of FoxP3 cells, and the expression of chemokine receptors on CD4+ and CD8+ T cells (CXCR3, CCR5, CCR4, CCR6, and CXCR4)\n* Evaluate the local expression of effector T cells (Teff)-attracting chemokines (CCR5, CXCL9, CXCL10 and CXCL11) and Treg-favoring chemokines (CCL22 and CXCL12) using IF and RT-PCR.\n\nOUTLINE:\n\nPatients receive celecoxib orally (PO) twice daily (BID), recombinant interferon alfa-2b intravenously (IV) over 20 minutes, and rintatolimod IV QD on days 1, 2,3,8,9,10,15,16 and 17 in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Recurrent and/or metastatic unresectable colorectal cancer with hepatic metastases\n* Hepatic metastases present which are amenable to biopsy\n* Prior treatment with, contra-indication to or refusal of a fluoropyrimidine, irinotecan, oxaliplatin and an anti-EGFR targeted therapy (if RAS wild-type \\[wt\\]) as well as a PD-1 or PD-L1 targeted drug if MSI-H/dMMR\n* No chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Have measurable disease per RECIST 1.1 criteria present\n* Ability to swallow and retain oral medication\n* Participants 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; 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* Platelet \\>= 75,000/uL\n* Hemoglobin \\>= 9 g/dL\n* Hematocrit \\>= 27%\n* Absolute neutrophil count (ANC) \\>= 1500/uL\n* Creatinine \\< = institutional upper limit of normal (ULN) OR\n* Creatinine clearance \\>= 50 mL/min for patients with creatinine levels greater than ULN\n* Total bilirubin =\\< 1.5 X institutional ULN or for patients with known Gilbert's Syndrome total bilirubin \\<= 3 x ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 X institutional ULN\n* Plasma amylase =\\< 1.5 X institutional ULN\n* Lipase =\\< 1.5 X institutional ULN\n* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment\n* Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation\n* Patients who are pregnant or nursing; women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening\n* Untreated central nervous system (CNS) metastases\n* Cardiac risk factors including:\n\n * Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent\n * Patients with a New York Heart Association classification of III or IV\n* History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with ulceration, bleeding or perforation in the lower bowel are not excluded\n* Prior allergic reaction or hypersensitivity to celecoxib, or non-steroidal antiinflammatory drugs (NSAIDs) or any study agents which would prevent completion of protocol therapy\n* Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required\n* Received an investigational agent within 30 days prior to enrollment\n* Unwilling or unable to follow protocol requirements\n* Patients with known serious mood disorders\n* Any additional condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive the study drugs"}, 'identificationModule': {'nctId': 'NCT03403634', 'briefTitle': 'Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Phase 2a Study Evaluating a Chemokine-Modulatory Regimen in Patients With Colorectal Cancer Metastatic to the Liver', 'orgStudyIdInfo': {'id': 'I 52917'}, 'secondaryIdInfos': [{'id': 'NCI-2017-02471', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 52917', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'P01CA234212', 'link': 'https://reporter.nih.gov/quickSearch/P01CA234212', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (celecoxib, interferon alfa-2b, rintatolimod)', 'description': 'Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Celecoxib', 'Other: Laboratory Biomarker Analysis', 'Biological: Recombinant Interferon Alfa-2b', 'Drug: Rintatolimod']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-', 'Celebrex', 'SC-58635', 'YM 177'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (celecoxib, interferon alfa-2b, rintatolimod)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (celecoxib, interferon alfa-2b, rintatolimod)']}, {'name': 'Recombinant Interferon Alfa-2b', 'type': 'BIOLOGICAL', 'otherNames': ['Alfatronol', 'Glucoferon', 'Heberon Alfa', 'IFN alpha-2B', 'Interferon alfa 2b', 'Interferon Alfa-2B', 'Interferon Alpha-2b', 'Intron A', 'Sch 30500', 'Urifron', 'Viraferon'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (celecoxib, interferon alfa-2b, rintatolimod)']}, {'name': 'Rintatolimod', 'type': 'DRUG', 'otherNames': ['Ampligen', 'Atvogen'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (celecoxib, interferon alfa-2b, rintatolimod)']}]}, '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': 'Sarbajit Mukherjee, MD', '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'}}}}