Renal Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
Interventions
BIOLOGICALHLA-A02 restricted HIG2
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Iwate Medical University
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Inclusion criteria
DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments PATIENTS CHARACTERISTICS 1. Patients who showed resistance to hormonal therapy and chemotherapy 2. Histological diagnosis is adenocarcinoma 3. HLA-A\*0201/0206 4. ECOG performance status of 0 to 2 5. Age ≥ 20 years, ≤80 years 6. WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg 7. life expectancy ≥ 3months 8. Able and willing to give valid written informed consent
Exclusion criteria
1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception) 4. Serious infections requiring antibiotics 5. Concomitant treatment with steroids or immunosuppressing agent 6. Other malignancy difficult to control. 7. Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 2 years | hematological and non-hematological adverse event |
Secondary
| Measure | Time frame |
|---|---|
| CTL reaction | 2 years |
Outcome results
None listed