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WT1 Peptid Vaccination in Carcinomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00153608
First received: September 8, 2005
Last updated: February 13, 2006
Last verified: September 2005
History of Changes
  Purpose

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


Condition Intervention Phase
WT1 Expressing Carcinoma
 Biological: WT1 126-134 peptide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas

Resource links provided by NLM:

MedlinePlus related topics: Wilms' Tumor
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Clinical efficacy

Secondary Outcome Measures:
  • Immune response
  • Safety

Estimated Enrollment: 25
Study Start Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153608

Contacts
Contact: Carmen Scheibenbogen, MD +49-30-8445-4576 carmen.scheibenbogen@charite.de

Locations
Germany
Hem&Onc Charité CBF Recruiting
Berlin, Germany, 12200
Contact: Carmen Scheibenbogen, MD     +49-30-8445-4576     carmen.scheibenbogen@charite.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité CBF
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00153608     History of Changes
Other Study ID Numbers: HaemaCBFWT104, EU
Study First Received: September 8, 2005
Last Updated: February 13, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013