Safety and Efficacy Study of Mix Vaccine in Prostate Carcinoma Patient

Prostatic Neoplasms Clinical Trial

Official title: Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Prostate Carcinoma Patient

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

Clinical Trial Description

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT02338700
• Study type: Interventional
• Source: Fuda Cancer Hospital, Guangzhou
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2015
• Completion date: August 2015