Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: External Beam Radiation Therapy (RT); Autologous Dendritic Cells
Intervention description: Day 1: Start external beam RT, 25 fractions from days 1-33 administered Monday through Friday only (no conventional external beam RT on days 6, 7, 13, 14, 20, 21, 27, or 28
Days 57-70: Surgery will occur 3-5 weeks after the final dose of external beam RT.
Day 78-91: First post-operative visit
Days 91-365: Clinical follow-up
Beyond day 365, follow-up will be conducted using the standard of care approach applicable to these patients for the determination of disease recurrence, progression and survival.; Prior to each injection on Arm B, patients may receive prophylactic doses of a first generation cephalosporin antibiotic per physician discretion.
Following each DC injection, Arm B patients will assess procedure-associated pain on a scale of 0-10. The next Monday following each DC injection, the patient will be called and questioned about such procedure associated toxicities.
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation; neoadjuvant; intratumoral; autologous; dendritic cells

Summary:

      The purpose of this study is to determine if injection of the participant's our own immune
      related white blood cells (called dendritic cells) into their tumor will strengthen their
      immune system to fight against their cancer.
    

Eligibility criteria:

        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).