Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT00503295
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00503295
Study Brief:
Protocol Section:
NCT00503295