A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
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
1 other identifier
interventional
32
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2009
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 31, 2016
August 1, 2015
3.9 years
October 15, 2009
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
6 months
Secondary Outcomes (4)
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.
Within 30 days of last dose of REOLYSIN
To assess progression-free survival (PFS) for the treatment regimen in the study population.
9-12 months
Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.
6 months
To determine overall survival with the treatment regimen in the study population
9-12 months
Interventions
3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
Eligibility Criteria
You may qualify if:
- 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.
- have measurable disease.
- be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions.
- have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
- have an ECOG Performance Score of ≤ 2.
- have a life expectancy of at least 3 months.
- 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.
- negative pregnancy test for females with childbearing potential.
You may not qualify if:
- receive concurrent therapy with any other investigational anticancer agent while on study.
- have a known past or current history of brain metastasis(es).
- be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- be a pregnant or breast-feeding woman.
- have clinically significant cardiac disease.
- have dementia or altered mental status that would prohibit informed consent.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oncolytics Biotechlead
- University of Texascollaborator
Study Sites (17)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260, United States
Advanced Oncology Associates
Armonk, New York, 10504, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Medical Oncology Associates of Wyoming Valley
Kingston, Pennsylvania, 18704, United States
Texas Oncology - Arlington South
Arlington, Texas, 76014, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Texas Oncology - Denton South
Denton, Texas, 76210, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104, United States
Texas Oncology - Garland
Garland, Texas, 75042, United States
Texas Oncology - Lewisville
Lewisville, Texas, 75067, United States
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, 78229, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78258-3912, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Mita, MD
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 20, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2013
Study Completion
August 1, 2015
Last Updated
March 31, 2016
Record last verified: 2015-08