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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Biological: Autologous Dendritic Cells; Procedure: External Beam Radiation Therapy (RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01347034

MCC-16441

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

External Beam Radiation Therapy (RT)

Active Comparator group

Description:

Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description

Treatment:

Procedure: External Beam Radiation Therapy (RT)

External Beam RT + DC Injection

Experimental group

Description:

Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description

Treatment:

Biological: Autologous Dendritic Cells

Procedure: External Beam Radiation Therapy (RT)