Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

Breast Neoplasms Clinical Trial

Official title:

Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338804
• Other study ID #: breast cancer MV
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 11, 2015
• Last updated: September 8, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2015
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1		2 years	Yes
Secondary	safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria		1 month	Yes
Secondary	immunology index	including lymphocyte sub-type number and function, and cytokines	2 years	No

External Links

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