WT1 Peptid Vaccination in Carcinomas

WT1 Expressing Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00153608
• Other study ID #: HaemaCBFWT104
• Secondary ID: EU
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: February 13, 2006
• Start date: April 2004

Study information

• Verified date: September 2005
• Source: Charite University, Berlin, Germany
• Contact: Carmen Scheibenbogen, MD
• Phone: +49-30-8445-4576
• Email: carmen.scheibenbogen[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• WT1 Expressing Carcinoma

Intervention

Biological:
• WT1 126-134 peptide

Locations

Country	Name	City	State
Germany	Hem&Onc Charité CBF	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy
Secondary	Immune response
Secondary	Safety