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

This is a single arm, pilot study designed to test the feasibility of using the CIVO
(Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for
percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection
surgery will be injected one to three days prior to surgery using the CIVO device. Minute
volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer
agents will be percutaneously injected in a columnar fashion through each of 8 needles into a
single enlarged solid tumor. Following the patient's biopsy surgery or tumor resection
surgery, the injected portion and a small uninjected portion will be used to determine the in
situ drug response in the tumor. None of the data from this evaluation will be shared with
patients or used to make clinical decisions. Study clinicians will have access to the
patient's health record for 1 year after the study to monitor patient treatment responses.
Such information will be used to help evaluate the correlation between clinical response and
tumor response assessed via CIVO.

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.