Status:
COMPLETED
Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Iwate Medical University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments
- PATIENTS CHARACTERISTICS
- Patients who showed resistance to hormonal therapy and chemotherapy
- Histological diagnosis is adenocarcinoma
- HLA-A\*0201/0206
- ECOG performance status of 0 to 2
- Age ≥ 20 years, ≤80 years
- 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
- life expectancy ≥ 3months
- Able and willing to give valid written informed consent
Exclusion
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breastfeeding
- Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- Serious infections requiring antibiotics
- Concomitant treatment with steroids or immunosuppressing agent
- Other malignancy difficult to control.
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01254838
Start Date
November 1 2008
End Date
December 1 2010
Last Update
December 7 2010
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