Safety And Efficacy Study Of Mix Vaccine In Pancreatic Carcinoma Patient

Study Overview

Safety and Efficacy Study of Mix Vaccine in Pancreatic Carcinoma Patient

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.

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.

Pancreatic Neoplasms

BIOLOGICAL: MV
OTHER: Standard Treatment

pancreatic cancer MV

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-10
First Submitted that Met QC Criteria 2015-01-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-12
First Posted (ACTUAL) 2015-01-14	Results First Posted N/A	Last Verified 2015-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: control Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line	BIOLOGICAL: MV 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 OTHER: Standard Treatment 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
ACTIVE_COMPARATOR: MV+control Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV).	BIOLOGICAL: MV 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 OTHER: Standard Treatment 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

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: control

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

BIOLOGICAL: MV

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

OTHER: Standard Treatment

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

ACTIVE_COMPARATOR: MV+control

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

BIOLOGICAL: MV

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

OTHER: Standard Treatment

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

Primary Outcome Measures	Measure Description	Time Frame
efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1		2 years

Secondary Outcome Measures	Measure Description	Time Frame
safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria		1 month
immunology index	including lymphocyte subtype number and function, cytokines	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1.Patients diagnosed with pancreatic carcinoma based on histology
2.Evaluable lesions on imaging study
3.Without known immunodeficiency
4.Age >18 and <80 years ago

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Kecheng Xu, MD, Fuda Cancer Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record