Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)
This trial is active, not recruiting.
|Condition||soft tissue sarcoma|
|Treatments||external beam radiation therapy (rt), autologous dendritic cells|
|Sponsor||H. Lee Moffitt Cancer Center and Research Institute|
|Collaborator||University of Florida|
|Start date||January 2011|
|End date||August 2013|
|Trial size||20 participants|
|Trial identifier||NCT01347034, MCC-16441|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Gainesville, FL||Shands University of Florida Department of Radiation Oncology||no longer recruiting|
|Jacksonville, FL||Shands Jacksonville Department of Radiation Oncology||no longer recruiting|
|Tampa, FL||H. Lee Moffitt Cancer Center and Research Institute||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)
time frame: 11 weeks per participant
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)
time frame: 11 weeks per participant
Male or female participants at least 18 years old.
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).
|Official title||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|
|Principal investigator||Alberto Chiappori, M.D.|
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