HLA-A02 restricted HIG2 in Renal Cell Carcinoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Renal Cell Carcinoma

Intervention / Treatment

Biological: HLA-A02 restricted HIG2

Study Type

Interventional

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
CTL reaction Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iwate Medical University

Collaborators

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

Investigators

Study Chair: Tomoaki Fujioka, Department of Urology, Iwate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)