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Phase 1
20 Years
80 Years
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information


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

Type of Study:

Interventional

Study Design:

N/A

Outcome Measure:

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

Outcome Description:

hematological and non-hematological adverse event

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Tomoaki Fujioka

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Urology, Iwate Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

IMU-H20-30-P1

NCT ID:

NCT01254838

Start Date:

November 2008

Completion Date:

December 2010

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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