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Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01254838
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: HLA-A02 restricted HIG2 Phase 1

Study Type : Interventional  (Clinical Trial)
Study Start Date : November 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. CTL reaction [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Departmet of Urology, Iwate Medical University
ClinicalTrials.gov Identifier: NCT01254838     History of Changes
Other Study ID Numbers: IMU-H20-30-P1
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: November 2008

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