CompletedPhase 2NCT00998192

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.

Checked against the public recordLast updated Mar 31, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations17
SponsorOncolytics Biotech
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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