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

December 2, 2010
December 6, 2010
November 2008
December 2010   (final data collection date for primary 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
hematological and non-hematological adverse event
Same as current
Complete list of historical versions of study NCT01254838 on ClinicalTrials.gov Archive Site
CTL reaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
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Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
Not Provided

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

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Interventional
Phase 1
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Renal Cell Carcinoma
Biological: HLA-A02 restricted HIG2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
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Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01254838
IMU-H20-30-P1
Yes
Departmet of Urology, Iwate Medical University
Iwate Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Tomoaki Fujioka Department of Urology, Iwate Medical University
Iwate Medical University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP