CompletedPhase 1

Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

China10 participantsStarted 2016-03-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)

Timeframe: 3 years since the beginning of the first vaccine

Trial details

NCT IDNCT02808416

SponsorGuangdong 999 Brain Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-31