Safety and Efficacy Study of REOLYSIN® in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung
NCT00503295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2014-10-02
Summary
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN® therapeutic reovirus is safe and effective in the treatment of patients with bone and soft tissue sarcomas metastatic to the lung.
Conditions
- Osteosarcoma
- Ewing Sarcoma Family Tumors
- Malignant Fibrous Histiocytoma
- Sarcoma, Synovial
- Fibrosarcoma
- Leiomyosarcoma
Interventions
- BIOLOGICAL
-
REOLYSIN®
REOLYSIN® is given intravenously at a dose of 3x10E10 TCID50 over 60 minutes on Days 1-5 of a 28 day cycle.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Karl Mettinger, MD, PhD · Oncolytics Biotech
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2011-02-28
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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