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Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254838
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University
December 2, 2010
December 7, 2010
December 7, 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 ]
hematological and non-hematological adverse event
Same as current
No Changes Posted
CTL reaction [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 1
Not Provided
Renal Cell Carcinoma
Biological: HLA-A02 restricted HIG2
Not Provided
Not Provided

*   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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01254838
IMU-H20-30-P1
Yes
Not Provided
Not Provided
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