Hepatocellular CarcinomaPhase 1NCT01266707
Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma
A Phase 1 study testing antiangiogenic paptide vaccine in people with Hepatocellular Carcinoma, run by Fukushima Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- antiangiogenic paptide vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Mar 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable or treatment-resistant patients with Hepatocellular carcinoma
- Measurable disease by CT scan
- ECOG performance status 0-2
- Life expectancy > 3 months
- Laboratory values as follows: 2,000/mm3 < WBC <15,000/mm3, Platelet counts > 75,000/mm3, Total Bilirubin < 1.5 mg/dl, Asparate transaminase < 150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
- HLA-A*2402
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Brest-feeder
- Active or uncontrolled infection
- Steroids or immunosuppressing agent dependent status
- Active or uncontrolled other malignancy
- Serious or uncured wound
- Decision of unsuitableness by principal investigator or physician-in charge
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Akira Kenjo, MD, +81-24-547-1111 ext. 2332, a-kenjo@fmu.ac.jp
Takashi Kimura, PhD & MD, +81-24-547-1111 ext. 2332, a-kenjo@fmu.ac.jp
About this study
Official title: Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma
The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.
Read the detailed description
It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- antiangiogenic paptide vaccine
- Keywords
- Hepatocellular carcinoma, peptide vaccine, VEGFR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiangiogenic paptide vaccineBiological
Also called VEGFR1 and VEGFR2 specific epitope vaccine
for drugs include administration time frame
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | VEGRF1, VEGFR2 Receives: Biological: antiangiogenic paptide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities as assessed by NCI-CACAE ver3
Measured: 3 months
Secondary outcomes (6)
Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
Measured: 3 months
CD8 population
Measured: 3 months
Change in level of regulatory T cells
Measured: 3 months
Objective response rate
Measured: 1 year
Feasibility
Measured: 1 year
Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startMar 2007
- Primary completionMar 2012 (estimated)
- Study completionMar 2013 (estimated)
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 Hepatocellular CarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fukushima Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Mitsukazu Gotoh, PhD & MD, Study chair, Fukushima Medical University, Department of Regeneration Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266707
- Sponsor's protocol ID
- 560
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
PubMed 12415261Ishizaki 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 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01266707
- Acronym / sponsor ID
- 560
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, peptide vaccine, VEGFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fukushima Medical UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- Mar 2007
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 24 Dec 2010 (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 assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.
Detailed description
It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: antiangiogenic paptide vaccineVEGRF1, VEGFR2 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unresectable or treatment-resistant patients with Hepatocellular carcinoma
- Measurable disease by CT scan
- ECOG performance status 0-2
- Life expectancy > 3 months
- Laboratory values as follows: 2,000/mm3 < WBC <15,000/mm3, Platelet counts > 75,000/mm3, Total Bilirubin < 1.5 mg/dl, Asparate transaminase < 150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
Key exclusion criteria (7 listed)
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Brest-feeder
- Active or uncontrolled infection
- Steroids or immunosuppressing agent dependent status
- Active or uncontrolled other malignancy
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 |
|---|---|---|
| antiangiogenic paptide vaccineAlso: VEGFR1 and VEGFR2 specific epitope vaccinefor drugs include administration time frame | Biological | Vaccine |
Primary outcome
Toxicities as assessed by NCI-CACAE ver3
Time frame: 3 months
6 secondary outcomes
Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration
Time frame: 3 months
CD8 population
Time frame: 3 months
Change in level of regulatory T cells
Time frame: 3 months
Objective response rate
Time frame: 1 year
Feasibility
Time frame: 1 year
Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Background: PubMed 12415261Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
- 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.
- Fukushima Medical University (Department of Regeneration Surgery)Link 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.
Mitsukazu Gotoh, PhD & MD study chair
Fukushima Medical University, Department of Regeneration Surgery
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 antiangiogenic paptide vaccine in people with Hepatocellular Carcinoma, run by Fukushima Medical 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 7 inclusion and 7 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 24 Dec 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akira Kenjo, MD (+81-24-547-1111 ext. 2332, a-kenjo@fmu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities as assessed by NCI-CACAE ver3 (time frame: 3 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 NCT01266707, 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 24 Dec 2010.