Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254838
• Other study ID #: IMU-H20-30-P1
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2010
• Last updated: December 6, 2010
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2008
• Source: Iwate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• HLA-A02 restricted HIG2

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Iwate Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hematological and non-hematological adverse event	2 years	Yes
Secondary	CTL reaction		2 years	Yes