Cancer.Phase 1/2NCT01584115
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
A Phase 1/2 study testing NY-ESO-1 combined with MPLA and NY-ESO-1 combined with MPLA vaccine in people with Cancer. and Melanoma., run by Instituto de Investigação em Imunologia at 1 site in Brazil.
Trial summary
This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer., Melanoma., Ovarian Cancer.
- What is being tested?
- NY-ESO-1 combined with MPLA and NY-ESO-1 combined with MPLA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jul 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.
Who cannot join
- Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.
Read the detailed description
The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.
- Conditions
- Cancer., Melanoma., Ovarian Cancer., Lung Cancer.
- Being tested
- NY-ESO-1 combined with MPLA, NY-ESO-1 combined with MPLA vaccine
- Keywords
- Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.
- Medical subject headings
- Neoplasms, Melanoma, Ovarian Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1 combined with MPLABiological
Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).
NY-ESO-1 combined with MPLA vaccineBiological
Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine
| Study group | Role | What they receive |
|---|---|---|
| NY-ESO-1 | Experimental | NY-ESO-1 combined with MPLA vaccine Receives: Biological: NY-ESO-1 combined with MPLA; Biological: NY-ESO-1 combined with MPLA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
CTCAE (Common Terminology Criteria for Adverse Events)
Measured: Six months after immunization.
Secondary outcomes (1)
Immunogenicity
IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).
Measured: Six months after immunization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer.Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigação em Imunologia
- Sponsor type
- University, hospital or other
- Collaborators
- Butantan Institute
- Responsible party
- Principal investigator, Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia
- Investigators
- Pedro Giavina-Bianchi, MD,PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584115
- Sponsor's protocol ID
- 6889
- Other IDs
- CNPq 577582/2008-9
- Status last verified
- Apr 2012
- First submitted
- 21 Apr 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
- ClinicalTrials.gov ID
- NCT01584115
- Acronym / sponsor ID
- 6889
- Conditions
- Cancer., Melanoma., Ovarian Cancer., Lung Cancer.
- Keywords
- Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto de Investigação em ImunologiaUniversity, hospital or other
- Collaborators
- Butantan Institute
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 24 Apr 2012 (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 study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.
Detailed description
The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NY-ESO-1 | Experimental | Biological: NY-ESO-1 combined with MPLA, Biological: NY-ESO-1 combined with MPLA vaccineNY-ESO-1 combined with MPLA vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.
Key exclusion criteria (1 listed)
- Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
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 |
|---|---|---|
| NY-ESO-1 combined with MPLAEach patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg). | Biological | NY-ESO-1 |
| NY-ESO-1 combined with MPLA vaccineImmunization os cancer patients with NY-ESO-1 combined with MPLA vaccine | Biological | NY-ESO-1 |
Primary outcome
Safety
Time frame: Six months after immunization.
CTCAE (Common Terminology Criteria for Adverse Events)
1 secondary outcome
Immunogenicity
Time frame: Six months after immunization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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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.
Pedro Giavina-Bianchi, MD,PhD principal investigator
University of Sao Paulo
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 NY-ESO-1 combined with MPLA and NY-ESO-1 combined with MPLA vaccine in people with Cancer. and Melanoma., run by Instituto de Investigação em Imunologia at 1 site in Brazil.
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 1 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 25 Apr 2012. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Giavina-Bianchi, PhD,MD ((5511) 26616098, pbianchi@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Six months after immunization.). It is what the study was designed to measure, not a finding.
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 25 Apr 2012.