MelanomaPhase 1NCT00112229
Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients
A Phase 1 study testing group 1, group 2 and group 3 in people with Melanoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- group 1, group 2 and group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2003to Jun 2012
- Phase
- Phase 1
- 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
- Histologically confirmed stage III or stage IV melanoma
- Tumor expression of Melan-A +/- Tyrosinase
- Human leukocyte antigen-A2 (HLA-A2) positive
Who cannot join
- Clinically significant heart disease
- Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
- History of immunodeficiency disease or autoimmune disease
- Coagulation or bleeding disorders
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide
The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Read the detailed description
Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.
The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.
- Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
- Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
- Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
- Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.
- Conditions
- Melanoma
- Being tested
- group 1, group 2, group 3, group 4
- Keywords
- Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, Tyrosinase peptide, CpG, Montanide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1Biological
Melan-A analog peptide + CpG + Montanide
group 2Biological
Melan-A natural peptide + CpG + Montanide
group 3Biological
Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
group 4Biological
Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Melan-A analog peptide + CpG + Montanide Receives: Biological: group 1 |
| group 2 | Experimental | Melan-A natural peptide + CpG + Montanide Receives: Biological: group 2 |
| group 3 | Experimental | Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide Receives: Biological: group 3 |
| group 4 | Experimental | Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide Receives: Biological: group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays
Measured: Change from baseline in CD8 T-cells reactivity at day 375
Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Measured: Change from baseline to day 375
Secondary outcomes (1)
In patients with measurable disease, tumor response will be assessed radiologically
Measured: Change from baseline in tumor response at day 375
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research
- Responsible party
- Principal investigator, Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
- Investigators
- Olivier Michielin, MD, Principal investigator, Ludwig Institute for Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112229
- Sponsor's protocol ID
- LUD 2000-018
- Status last verified
- Apr 2013
- First submitted
- 31 May 2005
- Last updated
- 22 Apr 2013
- Results posted
- No
Publications
Speiser DE, Lienard D, Rufer N, Rubio-Godoy V, Rimoldi D, Lejeune F, Krieg AM, Cerottini JC, Romero P. Rapid and strong human CD8+ T cell responses to vaccination with peptide, IFA, and CpG oligodeoxynucleotide 7909. J Clin Invest. 2005 Mar;115(3):739-46. doi: 10.1172/JCI23373.
PubMed 15696196Baumgaertner P, Jandus C, Rivals JP, Derre L, Lovgren T, Baitsch L, Guillaume P, Luescher IF, Berthod G, Matter M, Rufer N, Michielin O, Speiser DE. Vaccination-induced functional competence of circulating human tumor-specific CD8 T-cells. Int J Cancer. 2012 Jun 1;130(11):2607-17. doi: 10.1002/ijc.26297. Epub 2011 Aug 24.
PubMed 21796616
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide
- ClinicalTrials.gov ID
- NCT00112229
- Acronym / sponsor ID
- LUD 2000-018
- Conditions
- Melanoma
- Keywords
- Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, Tyrosinase peptide, CpG, Montanide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research
- Study start
- Apr 2003
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Jun 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.
The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Detailed description
Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.
The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.
- Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
- Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
- Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
- Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: group 1Melan-A analog peptide + CpG + Montanide |
| group 2 | Experimental | Biological: group 2Melan-A natural peptide + CpG + Montanide |
| group 3 | Experimental | Biological: group 3Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide |
| group 4 | Experimental | Biological: group 4Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed stage III or stage IV melanoma
- Tumor expression of Melan-A +/- Tyrosinase
- Human leukocyte antigen-A2 (HLA-A2) positive
Key exclusion criteria (4 listed)
- Clinically significant heart disease
- Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
- History of immunodeficiency disease or autoimmune disease
- Coagulation or bleeding disorders
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 |
|---|---|---|
| group 1Melan-A analog peptide + CpG + Montanide | Biological | group 1 |
| group 2Melan-A natural peptide + CpG + Montanide | Biological | group 2 |
| group 3Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide | Biological | group 3 |
| group 4Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide | Biological | group 4 |
Primary outcome
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays
Time frame: Change from baseline in CD8 T-cells reactivity at day 375
Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Time frame: Change from baseline to day 375
1 secondary outcome
In patients with measurable disease, tumor response will be assessed radiologically
Time frame: Change from baseline in tumor response at day 375
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 22 Apr 2013.
- Results publication: PubMed 15696196Speiser DE, Lienard D, Rufer N, Rubio-Godoy V, Rimoldi D, Lejeune F, Krieg AM, Cerottini JC, Romero P. Rapid and strong human CD8+ T cell responses to vaccination with peptide, IFA, and CpG oligodeoxynucleotide 7909. J Clin Invest. 2005 Mar;115(3):739-46. doi: 10.1172/JCI23373.
- Results publication: PubMed 21796616Baumgaertner P, Jandus C, Rivals JP, Derre L, Lovgren T, Baitsch L, Guillaume P, Luescher IF, Berthod G, Matter M, Rufer N, Michielin O, Speiser DE. Vaccination-induced functional competence of circulating human tumor-specific CD8 T-cells. Int J Cancer. 2012 Jun 1;130(11):2607-17. doi: 10.1002/ijc.26297. Epub 2011 Aug 24.
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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.
Olivier Michielin, MD principal investigator
Ludwig Institute for Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing group 1, group 2 and group 3 in people with Melanoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 inclusion and 4 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 22 Apr 2013. 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 Switzerland. 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 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.
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.
What does the primary outcome measure?
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays (time frame: Change from baseline in CD8 T-cells reactivity at day 375). The study lists 2 primary outcomes in all. 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 NCT00112229, which also lists 2 linked publications.
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 22 Apr 2013.