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Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University
ClinicalTrials.gov Identifier:
NCT01254838
First received: December 2, 2010
Last updated: December 6, 2010
Last verified: November 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
 Biological: HLA-A02 restricted HIG2
 Phase 1

Study Type: Interventional

Further study details as provided by Iwate Medical University:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    hematological and non-hematological adverse event


Secondary Outcome Measures:
  • CTL reaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254838

Sponsors and Collaborators
Iwate Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Tomoaki Fujioka Department of Urology, Iwate Medical University
  More Information

No publications provided

Responsible Party: Departmet of Urology, Iwate Medical University
ClinicalTrials.gov Identifier: NCT01254838     History of Changes
Other Study ID Numbers: IMU-H20-30-P1
Study First Received: December 2, 2010
Last Updated: December 6, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013