Safety and Efficacy Study of REOLYSIN® in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung

Completed · Phase 2

Conditions studied: Osteosarcoma, Ewing Sarcoma Family Tumors, Malignant Fibrous Histiocytoma, Sarcoma, Synovial, Fibrosarcoma, Leiomyosarcoma

In brief

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.

Key facts

Study ID

NCT00503295

Run by

Oncolytics Biotech

People needed

53

Starts

2007-06-01

Expected to finish

2011-04-01

Last updated by the study team

2014-10-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have a bone or soft tissue sarcoma metastatic to the lung deemed by a physician to be unresponsive to, or untreatable by, standard therapies. Acceptable histologies include only osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma
• have ≥ 2 measurable lesions in the lungs detectable on CT scan
• all residual adverse effects related to any prior anti-cancer therapy including, but not limited to, chemotherapy, biologic therapy, radiotherapy or surgical procedures must have resolved to Grade 1 or lower (as defined by the Common Terminology Criteria for Adverse Events, Version 3.0) before study therapy is initiated
• have received NO chemotherapy, radiotherapy, immunotherapy, hormonotherapy or surgery (except skin surgeries and minor biopsies) within 28 days prior to receiving REOLYSIN®
• have ECOG Performance Score of ≤ 2
• have life expectancy of at least 3 months
• Absolute neutrophils ≥ 1.5 x10\^9/L; hemoglobin ≥ 9.0g/dL; platelets ≥ 100 x 10\^9/L
• SGOT/SGPT (AST/ALT) ≤ 2.5 x ULN; bilirubin ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• negative pregnancy test for females of childbearing potential

You may not qualify if…

• have inadequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) less than 50% of predicted
• be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C
• have clinically significant pulmonary or cardiac disease
• have dementia or altered mental status that would prohibit informed consent
• have any other severe or acute 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 judgement of the Principal Investigator, would make the patient inappropriate for this study

Where it is running

• University of Michigan Medical School — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Montefiore Medical Center/Albert Einstein College of Medicine — The Bronx, New York, United States
• Institute of Drug Development, Cancer Therapy Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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