Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-17 @ 7:15 PM
Study NCT ID:
NCT00998192
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632500', 'term': 'reolysin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2009-10-15', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria.', 'timeFrame': 'Within 30 days of last dose of REOLYSIN'}, {'measure': 'To assess progression-free survival (PFS) for the treatment regimen in the study population.', 'timeFrame': '9-12 months'}, {'measure': 'Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.', 'timeFrame': '6 months'}, {'measure': 'To determine overall survival with the treatment regimen in the study population', 'timeFrame': '9-12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carcinoma', 'squamous cell', 'lung', 'REOLYSIN', 'chemotherapy', 'carboplatin', 'paclitaxel', 'Carcinoma, Squamous Cell of the Lung'], 'conditions': ['Metastatic or Recurrent Squamous Cell Carcinoma of the Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and safe in the treatment of squamous cell carinoma of the lung.', 'detailedDescription': 'Lung cancer remains the most common cancer and cause of cancer-related mortality in the United States. In 2008, there was an estimated 215,000 new cases of lung cancer diagnosed and roughly 162,000 deaths from lung cancer (NCI 2009). The majority (85%) of patients with a diagnosis of lung cancer will have non-small cell lung cancer (NSCLC).\n\nThe combination of paclitaxel and carboplatin has become the most commonly prescribed chemotherapy regimen for the treatment of advanced NSCLC in the United States. Laboratory studies of combinations of REOLYSIN with a variety of chemotherapeutic agents has shown that the combination of REOLYSIN and paclitaxel was invariably synergistic, even in cells with drug resistance or limited sensitivity to the reovirus. Moreover, reovirus activity was dramatically increased in the presence of the taxane.\n\nThe Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with squamous cell carinoma of the lung.\n\nResponse is a primary endpoint of this trial.\n\nThe safety of the treatment combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination.\n\nPatients may continue to receive chemotherapy combined with REOLYSIN for up to 8 cycles and may continue indefinitely on REOLYSIN monotherapy under this protocol, provided they have not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have histologically or cytologically confirmed metastatic stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent squamous cell carcinoma of the lung.\n* have measurable disease.\n* be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions.\n* have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.\n* have an ECOG Performance Score of ≤ 2.\n* have a life expectancy of at least 3 months.\n* absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9; Platelets ≥ 100 x10\\^9 (without platelet transfusion);Hemoglobin ≥ 9.0 g/dL (with or without RBC transfusion); Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN.\n* negative pregnancy test for females with childbearing potential.\n\nExclusion Criteria:\n\n* receive concurrent therapy with any other investigational anticancer agent while on study.\n* have a known past or current history of brain metastasis(es).\n* be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.\n* be a pregnant or breast-feeding woman.\n* have clinically significant cardiac disease.\n* have dementia or altered mental status that would prohibit informed consent.\n* have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.'}, 'identificationModule': {'nctId': 'NCT00998192', 'briefTitle': 'A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oncolytics Biotech'}, 'officialTitle': 'A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung', 'orgStudyIdInfo': {'id': 'REO 021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'REOLYSIN', 'type': 'BIOLOGICAL', 'description': '3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle'}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle'}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': '6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigative Clinical Research of Indiana, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10504', 'city': 'Armonk', 'state': 'New York', 'country': 'United States', 'facility': 'Advanced Oncology Associates', 'geoPoint': {'lat': 41.12648, 'lon': -73.71402}}, {'zip': '45042', 'city': 'Middletown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Signal Point Clinical Research Center, LLC', 'geoPoint': {'lat': 39.51506, 'lon': -84.39828}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Medical Oncology Associates of Wyoming Valley', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '76014', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Arlington South', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Bedford', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '76210', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Denton South', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75042', 'city': 'Garland', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Garland', 'geoPoint': {'lat': 32.91262, 'lon': -96.63888}}, {'zip': '75067', 'city': 'Lewisville', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Lewisville', 'geoPoint': {'lat': 33.04623, 'lon': -96.99417}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy & Research Center at UTHSCSA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258-3912', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Care Centers of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lynchburg Hematology Oncology Clinic', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'Alain Mita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncolytics Biotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}