- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02338804
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient
Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Biological treatment center in Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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).
|
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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
Time Frame: 2 years
|
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria
Time Frame: 1 month
|
1 month
|
|
immunology index
Time Frame: 2 years
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including lymphocyte sub-type number and function, and cytokines
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2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kecheng Xu, MD, Fuda Cancer Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- breast cancer MV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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