Metastatic MelanomaPhase 2NCT00153569
Multiepitope Peptide Vaccination in Melanoma
A Phase 2 study testing Tyrosinase, MAGE-3, GnTV in people with Metastatic Melanoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Tyrosinase, MAGE-3, GnTV
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Sep 2005
- 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 melanoma
- HLA-A1, -A2, -A24, -B44
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Multiepitope Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Metastatic Melanoma
This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients
- Conditions
- Metastatic Melanoma
- Being tested
- Tyrosinase, MAGE-3, GnTV
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyrosinase, MAGE-3, GnTVBiological
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 startMar 2003
- Study completionSep 2005
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 Metastatic MelanomaStudies 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
- NCT00153569
- Sponsor's protocol ID
- HaemaCBFMM03
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 26 May 2010
- Results posted
- No
Publications
Scheibenbogen C, Schadendorf D, Bechrakis NE, Nagorsen D, Hofmann U, Servetopoulou F, Letsch A, Philipp A, Foerster MH, Schmittel A, Thiel E, Keilholz U. Effects of granulocyte-macrophage colony-stimulating factor and foreign helper protein as immunologic adjuvants on the T-cell response to vaccination with tyrosinase peptides. Int J Cancer. 2003 Mar 20;104(2):188-94. doi: 10.1002/ijc.10961.
PubMed 12569574
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Multiepitope Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00153569
- Acronym / sponsor ID
- HaemaCBFMM03
- Conditions
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Sep 2005
- 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.
This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients
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 (2 listed)
- Metastatic melanoma
- HLA-A1, -A2, -A24, -B44
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tyrosinase, MAGE-3, GnTV | 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 26 May 2010.
- Background: PubMed 12569574Scheibenbogen C, Schadendorf D, Bechrakis NE, Nagorsen D, Hofmann U, Servetopoulou F, Letsch A, Philipp A, Foerster MH, Schmittel A, Thiel E, Keilholz U. Effects of granulocyte-macrophage colony-stimulating factor and foreign helper protein as immunologic adjuvants on the T-cell response to vaccination with tyrosinase peptides. Int J Cancer. 2003 Mar 20;104(2):188-94. doi: 10.1002/ijc.10961.
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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 Tyrosinase, MAGE-3, GnTV in people with Metastatic Melanoma, 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 2 inclusion and 0 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 26 May 2010. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT00153569, 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 26 May 2010.