In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 or HLA-A\*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors. In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402 or HLA-A\*0201-positive advanced solid tumor patients who are refractory to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Open Label, Non-Randomized, Safety/Efficacy study: 1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant. 2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
Shiga University of Medical Science Hospital
Ohtsu, Shiga, Japan
Evaluation of safety: the number of adverse events of vaccination therapy.
Time frame: 2 months
Evaluation of clinical efficacy: Overall survival.
Time frame: 2 months
Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.
Time frame: 2 months
Evaluation of clinical efficacy: Progression free survival.
Time frame: 2 months
Evaluation of clinical efficacy: Tumor markers.
Time frame: 2 months
Evaluation of clinical efficacy: Objective response rate.
Time frame: 2 months
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