Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma

Inclusion Criteria

• 18 years of age or over.
• At least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. Tumors should not be selected if the Investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis.
• Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.
• ECOG performance status of 0-2 (or a Karnofsky performance status of >50%)
• Labs required for enrollment (prior to microinjection):
• Absolute neutrophil count > 1000/mm3
• Platelet count > 50,000/mm3
• Hematocrit > 25%
• Creatinine <3.0 mg/dl
• Total Bilirubin <4.0 mg/dl
• Bilirubin <4.0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal
• PT and PTT ≤ 1.5 times the upper limit of normal

Exclusion Criteria

• Subjects with active fungal, viral, or bacterial infections.
• Pregnant women.
• Inability to give informed consent.
• Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
• Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.