A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 31, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Oncolytics Biotech
- Interventions being studied
- Biological: REOLYSIN; Drug: Paclitaxel; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterLos Angeles, California
- Ocala Oncology CenterOcala, Florida
- Illinois Cancer SpecialistsNiles, Illinois
- Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana
- Advanced Oncology AssociatesArmonk, New York
- Signal Point Clinical Research Center, LLCMiddletown, Ohio
- Medical Oncology Associates of Wyoming ValleyKingston, Pennsylvania
- Texas Oncology - Arlington SouthArlington, Texas
- Texas Oncology - BedfordBedford, Texas
- Texas Oncology - Denton SouthDenton, Texas
- Texas Oncology - Fort WorthFort Worth, Texas
- Texas Oncology - GarlandGarland, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 31, 2016. Always confirm current availability with the study team.