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Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

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ClinicalTrials.gov Identifier: NCT02338804
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Biological: MV Other: standard treatment Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: control
Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line
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 and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

Experimental: 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 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.

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 and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.




Primary Outcome Measures :
  1. efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria [ Time Frame: 1 month ]
  2. immunology index [ Time Frame: 2 years ]
    including lymphocyte sub-type number and function, and cytokines



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338804


Locations
China, Guangdong
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
Study Chair: Kecheng Xu, MD Fuda Cancer Hospital

Additional Information:
Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02338804     History of Changes
Other Study ID Numbers: breast cancer MV
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: January 2015

Keywords provided by Fuda Cancer Hospital, Guangzhou:
mix vaccine, breast neoplasms, immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs