Back to resultsWT1 Peptid Vaccination in Carcinomas
Primary Purpose
WT1 Expressing Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
WT1 126-134 peptide
Sponsored by
About this trial
This is an interventional treatment trial for WT1 Expressing Carcinoma
Eligibility 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
Sites / Locations
- Hem&Onc Charité CBFRecruiting
Outcomes
Primary Outcome Measures
Clinical efficacy
Secondary Outcome Measures
Immune response
Safety
Full Information
NCT ID
NCT00153608
First Posted
September 8, 2005
Last Updated
February 13, 2006
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00153608
Brief Title
WT1 Peptid Vaccination in Carcinomas
Official Title
Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
WT1 Expressing Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
WT1 126-134 peptide
Primary Outcome Measure Information:
Title
Clinical efficacy
Secondary Outcome Measure Information:
Title
Immune response
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Scheibenbogen, MD
Phone
+49-30-8445-4576
Email
carmen.scheibenbogen@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité CBF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hem&Onc Charité CBF
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Scheibenbogen, MD
Phone
+49-30-8445-4576
Email
carmen.scheibenbogen@charite.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
15920488
Citation
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.
Results Reference
background
Learn more about this trial
WT1 Peptid Vaccination in Carcinomas
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