Solid TumorsPhase 1/2NCT01949688
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors
A Phase 1/2 study testing HLA-A*2402 or A*0201 restricted peptides in people with Solid Tumors, run by Shiga University at 1 site in Japan.
Trial summary
In this study, the investigators examine using a combination of two types of HLA-A*2402 (or HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- HLA-A*2402 or A*0201 restricted peptides
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2010to Mar 2019
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
- ECOG performance status 0-1
- Age between 20 to 85
- Clinical efficacy can be evaluated by some methods
- No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
- Life expectancy > 3 months
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- Laboratory values as follows 1500/mm3 < WBC < 10000/mm3 Platelet count > 75000/mm3 15% < Lymphcyte fraction Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value
- HLA-A*2402 or HLA-A*0201
- Able and willing to give valid written informed consent
Who cannot join
- Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
- Myocardial infarction within six months before entry
- Breastfeeding and Pregnancy (woman of child bearing potential)
- Active and uncontrolled infectious disease
- Concurrent treatment with steroids or immunosuppressing agent
- Other malignancy requiring treatment
- Non-cured traumatic wound
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy
In this study, the investigators examine using a combination of two types of HLA-A*2402 (or HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.
In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.
- Conditions
- Solid Tumors
- Being tested
- HLA-A*2402 or A*0201 restricted peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-A*2402 or A*0201 restricted peptidesBiological
Open Label, Non-Randomized, Safety/Efficacy study:
- HLA-A*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
- HLA-A*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| HLA-A*2402 restricted peptides | Experimental | HLA-A*2402 restricted peptides with adjuvant Receives: Biological: HLA-A*2402 or A*0201 restricted peptides |
| HLA-A*0201 restricted peptides | Experimental | HLA-A*0201 restricted peptides with adjuvant Receives: Biological: HLA-A*2402 or A*0201 restricted peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety: the number of adverse events of vaccination therapy.
Measured: 2 months
Evaluation of clinical efficacy: Overall survival.
Measured: 2 months
Secondary outcomes (4)
Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.
Measured: 2 months
Evaluation of clinical efficacy: Progression free survival.
Measured: 2 months
Evaluation of clinical efficacy: Tumor markers.
Measured: 2 months
Evaluation of clinical efficacy: Objective response rate.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJun 2010
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo University
- Responsible party
- Principal investigator, Yataro Daigo, Shiga University
- Investigators
- Yataro Daigo, MD, PhD, Principal investigator, Shiga University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949688
- Sponsor's protocol ID
- SUMS-22-15
- Other IDs
- 22-15
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2013
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT01949688
- Acronym / sponsor ID
- SUMS-22-15
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Collaborators
- Tokyo University
- Study start
- Jun 2010
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 24 Sep 2013 (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 study, the investigators examine using a combination of two types of HLA-A*2402 (or HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.
In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLA-A*2402 restricted peptides | Experimental | Biological: HLA-A*2402 or A*0201 restricted peptidesHLA-A*2402 restricted peptides with adjuvant |
| HLA-A*0201 restricted peptides | Experimental | Biological: HLA-A*2402 or A*0201 restricted peptidesHLA-A*0201 restricted peptides with adjuvant |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
- ECOG performance status 0-1
- Age between 20 to 85
- Clinical efficacy can be evaluated by some methods
- No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
Key exclusion criteria (8 listed)
- Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
- Myocardial infarction within six months before entry
- Breastfeeding and Pregnancy (woman of child bearing potential)
- Active and uncontrolled infectious disease
- Concurrent treatment with steroids or immunosuppressing agent
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 |
|---|---|---|
| HLA-A*2402 or A*0201 restricted peptidesOpen Label, Non-Randomized, Safety/Efficacy study: 1. HLA-A*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant. 2. HLA-A*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant. | Biological | HLA-A*0201 restricted peptides, HLA-A*2402 restricted peptides |
Primary outcome
Evaluation of safety: the number of adverse events of vaccination therapy.
Time frame: 2 months
Evaluation of clinical efficacy: Overall survival.
Time frame: 2 months
4 secondary outcomes
Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.
Time frame: 2 months
Evaluation of clinical efficacy: Progression free survival.
Time frame: 2 months
Evaluation of clinical efficacy: Tumor markers.
Time frame: 2 months
Evaluation of clinical efficacy: Objective response rate.
Time frame: 2 months
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 19 Mar 2019.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Yataro Daigo, MD, PhD principal investigator
Shiga University
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 HLA-A*2402 or A*0201 restricted peptides in people with Solid Tumors, run by Shiga University at 1 site in Japan.
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 9 inclusion and 8 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 19 Mar 2019. 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 Japan. 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.
What does the primary outcome measure?
Evaluation of safety: the number of adverse events of vaccination therapy. (time frame: 2 months). 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?
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 19 Mar 2019.