MelanomaPhase 1/2NCT00306514
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
A Phase 1/2 study testing CYT004-MelQbG10 in people with Melanoma, run by Cytos Biotechnology AG at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- CYT004-MelQbG10
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Able and willing to complete all protocol requirements
- Age: 18 years and older
- Histologically confirmed stage III or IV melanoma
- HLA-A*0201 haplotype
- Expected survival of at least 6 months
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- ECOG performance status of 0 or 1
- At least one and no more than 2 previous systemic therapies for metastatic melanoma
- Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
- Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
- Adequate organ and bone marrow functions
- All adverse events (AEs) from prior anticancer therapy have resolved to ≤ Grade 1
- Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
- Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.
Who cannot join
- Pregnant or nursing
- Use of an investigational drug within 30 days before enrollment
- Known or suspected brain metastases
- Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
- Major surgery within 4 weeks prior to enrollment.
- Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug.
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- Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
- Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
- Active autoimmune diseases or severe allergies.
- Known type 1 allergy.
- Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
- Blood donation or loss of > 400mL within 8 weeks prior to inclusion.
- Hemoglobin (Hb) < 10g/dL
- Abuse of alcohol or other recreational drugs.
- Previous vaccination with a Melan-A peptide analogue.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Dermatology, Venerology and Allergy
Berlin, State of Berlin, 10117
About this study
Official title: A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.
- Conditions
- Melanoma
- Being tested
- CYT004-MelQbG10
- Keywords
- metastatic malignant melanoma of the skin
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT004-MelQbG10Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfram Sterry, MD, Principal investigator, University Hospital Charite, Berlin, D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306514
- Sponsor's protocol ID
- CYT004-MelQbG10 01
- Status last verified
- Sep 2007
- First submitted
- 23 Mar 2006
- Last updated
- 20 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00306514
- Acronym / sponsor ID
- CYT004-MelQbG10 01
- Conditions
- Melanoma
- Keywords
- metastatic malignant melanoma of the skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- First posted
- 24 Mar 2006 (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.
The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Able to provide written informed consent
- Able and willing to complete all protocol requirements
- Age: 18 years and older
- Histologically confirmed stage III or IV melanoma
- HLA-A*0201 haplotype
Key exclusion criteria (15 listed)
- Pregnant or nursing
- Use of an investigational drug within 30 days before enrollment
- Known or suspected brain metastases
- Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
- Major surgery within 4 weeks prior to enrollment.
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 |
|---|---|---|
| CYT004-MelQbG10 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
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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.
Wolfram Sterry, MD principal investigator
University Hospital Charite, Berlin, D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT004-MelQbG10 in people with Melanoma, run by Cytos Biotechnology AG 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 14 inclusion and 15 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: finished, as of the sponsor's last update on 20 Sep 2007. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 20 Sep 2007.