A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncolytics Biotech
• Collaborator: University of Texas
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.