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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01254838
Other study ID # IMU-H20-30-P1
Secondary ID
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
Accepts healthy volunteers
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


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
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