WT1 Peptid Vaccination in Carcinomas

February 13, 2006 updated by: Charite University, Berlin, Germany

Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas

In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide from the leukemia associated antigen WT1 together with immunological adjuvants KLH as T-helper protein and GM-CSF

Study Overview

Status

Unknown

Conditions

WT1 Expressing Carcinoma

Intervention / Treatment

Biological: WT1 126-134 peptide

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, 12200
    - Recruiting
    - Hem&Onc Charité CBF
    - Contact:
      
      Carmen Scheibenbogen, MD
      
      Phone Number: +49-30-8445-4576
      
      Email: carmen.scheibenbogen@charite.de

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Metastatic cancer, no standard treatment option
Resected cancer with minimal residual disease, no standard treatment option
WT-1 expression
HLA-A2

Exclusion Criteria:

Concurrent chemotherapy

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?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical efficacy

Secondary Outcome Measures

Outcome Measure
Safety
Immune response

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

Principal Investigator: Ulrich Keilholz, MD, Charité CBF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Keilholz U, Menssen HD, Gaiger A, Menke A, Oji Y, Oka Y, Scheibenbogen C, Stauss H, Thiel E, Sugiyama H. Wilms' tumour gene 1 (WT1) in human neoplasia. Leukemia. 2005 Aug;19(8):1318-23. doi: 10.1038/sj.leu.2403817.

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

April 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 14, 2006

Last Update Submitted That Met QC Criteria

February 13, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

HaemaCBFWT104
EU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.