NCT01254838

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
Last Updated

December 7, 2010

Status Verified

November 1, 2008

Enrollment Period

2.1 years

First QC Date

December 2, 2010

Last Update Submit

December 6, 2010

Conditions

Renal Cell Carcinoma

Outcome Measures

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

    hematological and non-hematological adverse event

    2 years

Secondary Outcomes (1)

  • CTL reaction

    2 years

Interventions

HLA-A02 restricted HIG2BIOLOGICAL

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Tomoaki Fujioka

    Department of Urology, Iwate Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 7, 2010

Study Start

November 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 7, 2010

Record last verified: 2008-11