NCT02338804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

January 11, 2015

Last Update Submit

September 8, 2015

Conditions

Breast Neoplasms

Keywords

mix vaccine, breast neoplasms, 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 therapy according to National Comprehensive Cancer Network (NCCN) guide line

Other: standard treatment

MV+control

EXPERIMENTAL

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

Biological: MVOther: standard treatment

Interventions

MVBIOLOGICAL

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 injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.

MV+control
standard treatmentOTHER

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.

MV+controlcontrol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with breast 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue 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)