Safety and Efficacy Study of Mix Vaccine in Prostate Carcinoma Patient

Phase 1

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Biological: MV; Other: standard treatment

• Registration Number: NCT02338700
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief 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.

Detailed 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 Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-11
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients diagnosed with prostate carcinoma based on histology
• Evaluable lesions on imaging study
• Without known immunodeficiency
• Age >18 and <80 years ago

Exclusion Criteria

• Patients is unable or unwilling to sign informed consent
• Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
• Positive HIV and/or RPR (rapid plasma reagin)
• Female patient who is pregnant or breast feeding
• Patients, based on the opinion pf the investigator, should not be enrolled into this study
• Prior anti-cancer vaccine or biological immunotherapy
• Allergic to any known ingredient of the MV compound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MV+control	MV	Patients in this group will be receiving both standard treatment according to NCCN guide line and simultaneous injection of mix vaccine (MV)
MV+control	standard treatment	Patients in this group will be receiving both standard treatment according to NCCN guide line and simultaneous injection of mix vaccine (MV)
Control	standard treatment	Patients in this group will be receiving standard treatment according to National Comprehensive Cancer Network (NCCN) guide line

Primary Outcome Measures

Name	Time	Method
efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1	2 years

Secondary Outcome Measures

Name	Time	Method
immunology index	2 years	including lymphocyte subtype number and function, cytokines
safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria	1 month

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China