Study on TVEC and Preoperative Radiation for Sarcoma (8 ml Dose)

Inclusion Criteria

• Must provide informed consent to participate.
• Have a confirmed diagnosis of locally advanced soft tissue sarcoma that cannot be removed with clear margins, making preoperative radiotherapy appropriate.
• Includes certain stages of disease that are not suitable for surgery alone due to the inability to achieve clear margins.
• Includes metastatic disease where radiotherapy and surgery are indicated, except for certain types like GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas, and low-grade myxoid liposarcomas.
• Previous treatments like chemotherapy, immunotherapy, or targeted therapy are allowed if completed at least 1 year before joining the study.
• No prior treatment with TVEC or tumor vaccines.
• No prior radiation to the same tumor area.
• Must be 18 years or older.
• Open to all genders and ethnic groups.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have a tumor that is at least 5 cm in size and can be measured by CT scan or MRI.
• Must have a tumor that can be injected directly or with ultrasound guidance.

Exclusion Criteria

• Certain types of sarcomas like GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas, and low-grade myxoid liposarcomas.
• Sarcomas associated with immune deficiency conditions like hereditary immune deficiency, HIV, organ transplant, or leukemia.
• Sarcomas located in the retroperitoneal area or internal organs.
• History of inflammatory bowel disease or other autoimmune diseases like rheumatoid arthritis or lupus.
• History of other cancers within the past 3 years, unless treated with curative intent and no active disease.
• History of autoimmune diseases or removal of the spleen.
• Active herpes skin lesions or need for anti-herpetic drugs.
• Recent use of non-oncology vaccines within 28 days before the study.
• Use of blood thinners like warfarin, unless on a stable dose of low molecular weight heparin.
• Positive tests for HIV, hepatitis B, or hepatitis C.
• Pregnant or breastfeeding women, or those planning to become pregnant during the study.
• Not willing to use effective contraception during and after the study.
• Participation in another investigational study within 30 days before this study.
• Previous participation in this study.
• Evidence of cancer spread to the brain.
• Allergic reactions to similar drugs as TVEC.
• Uncontrolled illnesses like heart failure or psychiatric conditions.
• Use of immunosuppressive therapies.
• Abnormal blood test results, such as low hemoglobin or high liver enzymes.