WT1 Peptid Vaccination in Carcinomas | NCT00153608

Studies
WT1 Peptid Vaccination in Carcinomas

NCT00153608

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Feb 14, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

WT1 Expressing Carcinoma

Interventions

WT1 126-134 peptide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EU

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2006

Last Update Posted Date

Feb 14, 2006Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
WT1 126-134 peptide	Biological

Measure	Description	Time Frame
Clinical efficacy

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carmen Scheibenbogen, MD	Contact	+49-30-8445-4576		carmen.scheibenbogen@charite.de

Overall Officials

Name	Affiliation	Role
Ulrich Keilholz, MD	Charité CBF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hem&Onc Charité CBF	Recruiting	Berlin		12200	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15920488	Background	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.