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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: 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 ]

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).


Original Primary Outcome: Number of Participants with Enhanced T Lymphocyte Immune Response Specific for STS-TAAs [ Time Frame: 11 weeks per participant ]

Investigate the ability of an intensified RT regimen (namely, conventional RT with a high-dose hypofractionated boost) and DC administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. The study will require 21 patients in each arm for a total of 42 patients.


Current Secondary Outcome: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: 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.


Original Secondary Outcome: Number of Participants with Adverse Events [ Time Frame: 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 will be performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention will be paid to DC injection and biopsy related toxicity.


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: May 2, 2011
Date Started: January 2011
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016