A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
NCT00998192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2016-03-31
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.
Conditions
- Metastatic or Recurrent Squamous Cell Carcinoma of the Lung
Interventions
- BIOLOGICAL
-
REOLYSIN
3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
- DRUG
-
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
- DRUG
-
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
Sponsors & Collaborators
-
University of Texas
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Alain Mita, MD · Cedars-Sinai Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2013-09-30
- Completion
- 2015-08-31
Countries
- United States
Study Locations
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