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WT1 Peptid Vaccination in Carcinomas

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ClinicalTrials.gov Identifier: NCT00153608
Recruitment Status : Unknown
Verified September 2005 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : February 14, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
WT1 Expressing Carcinoma Biological: WT1 126-134 peptide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Clinical efficacy

Secondary Outcome Measures :
  1. Immune response
  2. Safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 14, 2006
Last Verified: September 2005

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