Status:
COMPLETED
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
Lead Sponsor:
Oncolytics Biotech
Collaborating Sponsors:
University of Texas
Conditions:
Metastatic or Recurrent Squamous Cell Carcinoma of the Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 trea...
Detailed Description
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 de...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00998192
Start Date
October 1 2009
End Date
August 1 2015
Last Update
March 31 2016
Active Locations (17)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Ocala Oncology Center
Ocala, Florida, United States, 34471
3
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
4
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States, 46260