Breast CancerPhase 1/2NCT00677326
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer
A Phase 1/2 study testing VEGFR1 and VEGFR2 in people with Breast Cancer, run by Tokyo University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- VEGFR1 and VEGFR2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- May 2008to May 2009
- 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 or recurrent breast cancer
- Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
- Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
- ECOG performance status 0-2
- Life expectancy > 3 months
- HLA-A*0201
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- Laboratory values as follows
- 2000/mm3<WBC<15000/mm3
- Platelet count>100000/mm3
- Bilirubin < 3.0mg/dl
- Asparate transaminase < 150IU/L
- Alanine transaminase < 150IU/L
- Creatinine < 3.0mg/dl
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Unhealed external wound
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- Uncontrolled brain and/or intraspinal lesion(s)
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
Japan1 site
The Institute of Medical Science, the University of Tokyo
Minato-ku, Tokyo, 108-8639
About this study
Official title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients.
Read the detailed description
VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of the vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.
- Conditions
- Breast Cancer
- Being tested
- VEGFR1 and VEGFR2
- Keywords
- HLA-A*0201, Peptide Vaccine, VEGFR1, VEGFR2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGFR1 and VEGFR2Biological
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Peptide administered Receives: Biological: VEGFR1 and VEGFR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Measured: 2 months
Secondary outcomes (1)
To evaluate immunological responses
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 posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009 (estimated)
- Study completionMay 2009
Why it stopped: Difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Naohide Yamashita, MD/PhD, Study chair, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677326
- Sponsor's protocol ID
- Breast-A02-I, II
- Status last verified
- May 2009
- First submitted
- 12 May 2008
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072.
PubMed 12070285Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
PubMed 17020992Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
PubMed 15930316
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
- ClinicalTrials.gov ID
- NCT00677326
- Acronym / sponsor ID
- Breast-A02-I, II
- Conditions
- Breast Cancer
- Keywords
- HLA-A*0201, Peptide Vaccine, VEGFR1, VEGFR2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- May 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- May 2009 (actual)
- First posted
- 14 May 2008 (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 the safety and time to progression of HLA-A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients.
Detailed description
VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of the vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: VEGFR1 and VEGFR2Peptide administered |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Advanced or recurrent breast cancer
- Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
- Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
- ECOG performance status 0-2
- Life expectancy > 3 months
Key exclusion criteria (8 listed)
- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Unhealed external wound
- 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 |
|---|---|---|
| VEGFR1 and VEGFR2Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. | Biological | A |
Primary outcome
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Time frame: 2 months
1 secondary outcome
To evaluate immunological responses
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
- Background: PubMed 12070285Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072.
- Background: PubMed 17020992Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
- Background: PubMed 15930316Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
- Research Hospital, the Institute of Medical Science, the University of TokyoLink provided by the sponsor.
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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.
Naohide Yamashita, MD/PhD study chair
Tokyo 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 VEGFR1 and VEGFR2 in people with Breast Cancer, run by Tokyo 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 14 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: stopped early, as of the sponsor's last update on 29 Dec 2009. 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 was stopped early (reason given: Difficulty in recruiting). 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?
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) (time frame: 2 months). 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 NCT00677326, which also lists 3 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 29 Dec 2009.