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 ]
Original Primary Outcome: Number of Participants with Enhanced T Lymphocyte Immune Response Specific for STS-TAAs [ Time Frame: 11 weeks per participant ]
Current Secondary Outcome: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: 11 weeks per participant ]
Original Secondary Outcome: Number of Participants with Adverse Events [ Time Frame: 11 weeks per participant ]
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