Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)	11 weeks per participant	Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)	11 weeks per participant	Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.

Locations (3): Shands University of Florida Department of Radiation Oncology
🇺🇸
Gainesville, Florida, United States
Shands Jacksonville Department of Radiation Oncology
🇺🇸
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Shands University of Florida Department of Radiation Oncology
🇺🇸Gainesville, Florida, United States