NCT00153608

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

February 14, 2006

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

February 13, 2006

Conditions

WT1 Expressing Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy

Secondary Outcomes (2)

  • Immune response

  • Safety

Interventions

WT1 126-134 peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Concurrent chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hem&Onc Charité CBF

Berlin, 12200, Germany

RECRUITING

Related 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. doi: 10.1038/sj.leu.2403817.

    PMID: 15920488BACKGROUND

Study Officials

  • Ulrich Keilholz, MD

    Charité CBF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Scheibenbogen, MD

CONTACT

+49-30-8445-4576carmen.scheibenbogen@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2004

Last Updated

February 14, 2006

Record last verified: 2005-09

Locations

DE(1)