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Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HLA-A02 restricted HIG2
Sponsored by
Iwate Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Renal Cell Carcinoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    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
    hematological and non-hematological adverse event

    Secondary Outcome Measures

    CTL reaction

    Full Information

    First Posted
    December 2, 2010
    Last Updated
    December 6, 2010
    Sponsor
    Iwate Medical University
    Collaborators
    Human Genome Center, Institute of Medical Science, University of Tokyo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01254838
    Brief Title
    Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Iwate Medical University
    Collaborators
    Human Genome Center, Institute of Medical Science, University of Tokyo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Cell Carcinoma

    7. Study Design

    Study Phase
    Phase 1

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    HLA-A02 restricted HIG2
    Primary Outcome Measure Information:
    Title
    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
    Description
    hematological and non-hematological adverse event
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    CTL reaction
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility Criteria
    Inclusion Criteria: DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments PATIENTS CHARACTERISTICS Patients who showed resistance to hormonal therapy and chemotherapy Histological diagnosis is adenocarcinoma HLA-A*0201/0206 ECOG performance status of 0 to 2 Age ≥ 20 years, ≤80 years 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 life expectancy ≥ 3months Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding Patients willing to childbearing ( Refusal or inability to use effective means of contraception) Serious infections requiring antibiotics Concomitant treatment with steroids or immunosuppressing agent Other malignancy difficult to control. Decision of unsuitableness by principal investigator or physician-in-charge
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomoaki Fujioka
    Organizational Affiliation
    Department of Urology, Iwate Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

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