This study will evaluate a type of immunotherapy in which the patient's immune system will be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be collected from blood and cultured to yield autologous DC. The DC will be mixed with purified peptides from the CD133 antigen. The DC vaccine will be given back to the patient over several months. The goal is to stimulate the patient's immune system to CD133 to kill the patient's glioblastoma tumor cells.
Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of cancer cells and is associated with shortened survival. CD133 positive cancer stem cells are resistant to chemotherapy. Patients with recurrent glioblastoma who have the HLA A2 phenotype will receive autologous vaccine of DC pulsed with purified peptides from CD133. Approximately 20 patients with any recurrence of glioblastoma multiforme (GBM) will be treated. After informed consent and screening, patients will undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). Monocytes will be purified and cultured into dendritic cells (DC) that are pulsed with purified peptides from CD133 antigen. The pulsed dendritic cells will then be aliquoted and frozen. Patients will have the autologous DCs reinfused intradermally. Patients will receive at least four intradermal injections of the autologous DC vaccine and additional vaccines during a maintenance phase. The goal is to induce a cytotoxic T cell response to CD133 positive cells. The primary objective of the study is to assess safety and tolerability. Clinical response rates will be monitored as well as the immune responses to CD133.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
autologous dendritic cells pulsed with peptide antigens
University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
JFK New Jersey Neuroscience Institute
Edison, New Jersey, United States
Penn State Hershey Neuroscience Institute
Hershey, Pennsylvania, United States
Baylor Research Institute - Charles A. Sammons Cancer Center
Dallas, Texas, United States
Safety and tolerability of an autologous ICT-121 DC vaccine
To assess safety of the autologous ICT-121 DC vaccine the following will be monitored: Serious Adverse events, treatment emergent adverse events, treatment related toxicities
Time frame: 2-3 years
Response rate and immune response to autologous ICT-121 DC vaccine
The following parameters for response rate and immune response will be measured: The rates of OS and PFS assessed every 2 months until the end of the study; Health-related quality of life parameters in patients treated as above; Post vaccination biopsy/resection (optional) - Assess antigen expression; Overall response rate, defined as the percentage of patients showing either partial response or complete response, will be assessed in patients with measurable disease on MRI; Predictors of response; Immune Response (cytotoxic T-Cell response) to the ICT-121 DC vaccine epitopes.
Time frame: 2-3 years
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