Clinical trial NCT02338804: Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient
Official title: Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Keywords: mix vaccine, breast neoplasms, immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
timeFrame: 2 years
Secondary outcomes:
measure: safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria
timeFrame: 1 month
measure: immunology index
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Kecheng Xu, MD
role: STUDY_CHAIR
References: