Solid Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHLA-A*2402 or A*0201 restricted peptides
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.
Sponsors
Tokyo University
Shiga University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason. 2. ECOG performance status 0-1 3. Age between 20 to 85 4. Clinical efficacy can be evaluated by some methods 5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks 6. Life expectancy \> 3 months 7. Laboratory values as follows 1500/mm3 \< WBC \< 10000/mm3 Platelet count \> 75000/mm3 15% \< Lymphcyte fraction Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value 8. HLA-A\*2402 or HLA-A\*0201 9. Able and willing to give valid written informed consent
Exclusion criteria
1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. Myocardial infarction within six months before entry 3. Breastfeeding and Pregnancy (woman of child bearing potential) 4. Active and uncontrolled infectious disease 5. Concurrent treatment with steroids or immunosuppressing agent 6. Other malignancy requiring treatment 7. Non-cured traumatic wound 8. Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety: the number of adverse events of vaccination therapy. | 2 months |
| Evaluation of clinical efficacy: Overall survival. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels. | 2 months |
| Evaluation of clinical efficacy: Progression free survival. | 2 months |
| Evaluation of clinical efficacy: Tumor markers. | 2 months |
| Evaluation of clinical efficacy: Objective response rate. | 2 months |
Countries
Japan
Outcome results
None listed