Osteosarcoma Clinical Trial
Official title:
A Phase 2 Study of Intravenous REOLYSIN® (Wild-Type Reovirus) in the Treatment of Patients With Bone and Soft Tissue Sarcomas Metastatic to the Lung
Verified date | May 2012 |
Source | Oncolytics Biotech |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | April 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical School | Ann Arbor | Michigan |
United States | Montefiore Medical Center/Albert Einstein College of Medicine | Bronx | New York |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Institute of Drug Development, Cancer Therapy Research Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Oncolytics Biotech |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete response (CR) and partial response (PR) as well as prolonged stabilization of disease (SD) will be considered indicative of response. RECIST criteria will be utilized to assess radiographic response. | For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met. For SD, follow-up measurements must have met the SD criteria at least once after trial entry at a minimum interval of 12 weeks. | No | |
Secondary | Safety data, including laboratory parameters and adverse events, will be collected for all patients in order to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of REOLYSIN®. | within 30 days of the last dose of REOLYSIN® | Yes |
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