External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
Soft Tissue Sarcoma

About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Sarcoma, Intratumoral injection, Dendritic cells, Neo-adjuvant treatment, Immunotherapy, Pheresis, Radiation
Eligibility Criteria
Inclusion Criteria: Intermediate or high grade sarcoma as determined by pathology review Musculoskeletal tumor in extremities, trunk or chest wall. Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter. Clinical Stage T2N0M0 (AJCC 6th edition) Patient is not a candidate for neoadjuvant chemotherapy. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1. No steroid therapy within 4 weeks of first dendritic cell administration. No coagulation disorder. Patient's written informed consent. No contraindication to resection. Adequate organ function (measured within a week of beginning treatment). White blood count (WBC) > 3,000/mm to the third power and absolute neutrophil count (ANC) >1500/mm to the third power Platelets > 100,000/mm to the third power 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 radiation. Exclusion Criteria: Retroperitoneal location. Gastrointestinal stromal tumor (GIST). Demonstrated metastatic disease. Prior radiation therapy if the current tumor is locally recurrent after prior resection. Concurrent treatment with any anticancer agent other than radiation as dictated by the protocol. Bleeding disorder. H.I.V. infection or other primary immunodeficiency disorder. Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate). 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). ECOG performance status of 2, 3 or 4.
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
Arms of the Study
Arm 1
Experimental
EBRT + DC Injection + Resection
Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention.