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

Launched by ONCOLYTICS BIOTECH · Jul 16, 2007

Keywords

ClinConnect Summary

Sarcomas are uncommon mesenchymal malignancies that encompass a variety of tumors of soft tissue or bone. Included in this study are patients with osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, leiomyosarcoma and fibrosarcoma. Patients with these lesions presenting with metastatic disease remain largely incurable. In all sarcomas, the lungs are by far the most frequent site of metastases.

There is a need for new therapies that have activity against these types of sarcomas. REOLYSIN® is an unmodified oncolytic reovirus which replicates selective...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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