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Completed

NCT Number: NCT01254838

Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma

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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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HLA-A02 restricted HIG2

Biological

Primary outcomes

  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 outcomes

  1. CTL reaction

    Time frame: 2 years

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Iwate Medical University

Other

Collaborators

  • Human Genome Center, Institute of Medical Science, University of Tokyo

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 7, 2010
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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