A Phase II Study Evaluating Neoadjuvant Administration of High Dose Radiation Therapy and Intratumoral Autologous Dendritic Cells in Patients With High-risk Soft Tissue Sarcomas

Inclusion Criteria:

- Intermediate or High grade (AJCC 7th edition Grade 3 and 4 or Grade 2 and 3 of a 3
tier system) STS as determined by local pathology diagnostic biopsy specimen review

- Musculoskeletal tumor in extremities, trunk or chest wall

- Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter as
measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1

- Clinical Stage T2N0M0 (AJCC 7th edition)

- Age ≥18 years at time of consent

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1

- Patient's written study specific, Institutional Review Board (IRB) stamped informed
consent.

- Adequate organ function (measured within a week prior to beginning treatment for Arm
B and within 2 weeks of beginning treatment for Arm A): white blood count (WBC) >
3,000/mm³ and absolute neutrophil count (ANC) >1500/mm³; Platelets > 100,000/mm³;
Hematocrit > 25%; Bilirubin < 2.0 mg/dL; Creatinine < 2.0 mg/dL, or creatinine
clearance > 60 mL/min

- Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from RT.

Exclusion Criteria:

- Retroperitoneal or Head and Neck primary locations

- Gastrointestinal stromal tumor (GIST)

- Demonstrated metastatic disease

- Contraindication to resection

- Prior RT if the current tumor is locally recurrent after prior resection

- Concurrent treatment with any anticancer agent other than RT as dictated by the
protocol

- Prior chemotherapy for the pre-surgical treatment of the primary tumor (neoadjuvant
chemotherapy)Bleeding/coagulation disorder

- Human Immunodeficiency Virus (HIV) infection or other primary immunodeficiency
disorder

- Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids,
azathioprine, cyclosporin, methotrexate)

- Steroid therapy within 4 weeks of first DC administration

- Any serious ongoing infection

- Pregnant or lactating women. Patients in reproductive age must agree to use
contraceptive methods for the duration of the study (*A pregnancy test will be
obtained before treatment).