Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

Phase 1

Completed

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT01254838
• Lead Sponsor: Iwate Medical University

Brief Summary

The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-06
• Last Update Submitted: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CTL reaction	2 years