Safety and Efficacy Study of Mix Vaccine in Prostate Carcinoma Patient

NCT02338700 | Completed Phase 1 DMC

• 1 other identifier: prostate cancer MV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

mix vaccine, prostate carcinoma, immunotherapy

Outcome Measures

Primary Outcomes (1)

• efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1

  2 years

Secondary Outcomes (2)

• safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria

  1 month

• immunology index

  2 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in this group will be receiving standard treatment according to National Comprehensive Cancer Network (NCCN) guide line

Other: standard treatment

MV+control

EXPERIMENTAL

Patients in this group will be receiving both standard treatment according to NCCN guide line and simultaneous injection of mix vaccine (MV)

Biological: MV; Other: standard treatment

Interventions

MV BIOLOGICAL

MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for

MV+control

standard treatment OTHER

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

Control; MV+control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related Links

• related information

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kecheng Xu, MD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2015
• First Posted: January 14, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 10, 2015

Record last verified: 2015-01

Locations

CN (1)