Clinical trial NCT02808416: Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)
Official title: Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Cancer
Neoplasm Metastases
Keywords: Solid tumors
Brain metastases
DC vaccine
Personalized vaccine
Tumor antigens
Lead sponsor: Guangdong 999 Brain Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tricision Biotherapeutics Inc
name: Zhuhai Trinomab Pharmaceutical Co., Ltd.
name: Jinan University Guangzhou
First posted: 2016-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy will be observed in this study.

Detailed description: This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM criteria, progression-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

* Solid tumor with brain metastases.
* Patients at the age of 18-65.
* Patients undergo tumor resection or biopsy.
* Patients with Karnofsky scores \> or =70
* Patients with normal range of hematologic and metabolic test results.
* Patients must have no corticosteroids treatment at least one week before vaccination.
* Patients capable of understanding the study and signed informed consent.

Exclusion Criteria:

* Infectious diseases HIV, HBV, HCV.
* Documented immunodeficiency.
* Documented autoimmune disease.
* Breast feeding females.
* Pregnant women.
* Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
* Patient inability to participate as determined by PI discretion.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)
timeFrame: 3 years since the beginning of the first vaccine
Secondary outcomes:
measure: Antitumor specific T cell response
timeFrame: 4 weeks after the last vaccine
measure: Progression-free survival
timeFrame: 24 months since the beginning of the first vaccine
measure: Overall survival
timeFrame: 3 years since the beginning of the first vaccine
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong 999 Brain Hospital
state: Guangdong
Study officials:
affiliation: Guangdong 999 Brain Hospital
name: Jian Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang QT, Nie Y, Sun SN, Lin T, Han RJ, Jiang J, Li Z, Li JQ, Xiao YP, Fan YY, Yuan XH, Zhang H, Zhao BB, Zeng M, Li SY, Liao HX, Zhang J, He YW. Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. Cancer Immunol Immunother. 2020 Jul;69(7):1375-1387. doi: 10.1007/s00262-020-02496-w. Epub 2020 Feb 20.