WT1 Expressing CarcinomaPhase 2NCT00153608
WT1 Peptid Vaccination in Carcinomas
A Phase 2 study testing WT1 126-134 peptide in people with WT1 Expressing Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- WT1 Expressing Carcinoma
- What is being tested?
- WT1 126-134 peptide
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic cancer, no standard treatment option
- Resected cancer with minimal residual disease, no standard treatment option
- WT-1 expression
- HLA-A2
Who cannot join
- Concurrent chemotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hem&Onc Charité CBF
Berlin, 12200
Carmen Scheibenbogen, MD, +49-30-8445-4576, carmen.scheibenbogen@charite.de
About this study
Official title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas
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
- Conditions
- WT1 Expressing Carcinoma
- Being tested
- WT1 126-134 peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WT1 126-134 peptideBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Secondary outcomes (2)
Immune response
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WT1 Expressing CarcinomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Keilholz, MD, Principal investigator, Charité CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153608
- Sponsor's protocol ID
- HaemaCBFWT104
- Other IDs
- EU
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 14 Feb 2006
- Results posted
- No
Publications
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.
PubMed 15920488
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas
- ClinicalTrials.gov ID
- NCT00153608
- Acronym / sponsor ID
- HaemaCBFWT104
- Conditions
- WT1 Expressing Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metastatic cancer, no standard treatment option
- Resected cancer with minimal residual disease, no standard treatment option
- WT-1 expression
- HLA-A2
Key exclusion criteria (1 listed)
- Concurrent chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WT1 126-134 peptide | Biological | – |
Primary outcome
Clinical efficacy
2 secondary outcomes
Immune response
Safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2006.
- Background: PubMed 15920488Keilholz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Keilholz, MD principal investigator
Charité CBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WT1 126-134 peptide in people with WT1 Expressing Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Scheibenbogen, MD (+49-30-8445-4576, carmen.scheibenbogen@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2006.