Esophageal CancerPhase 1NCT00682227
Peptide Vaccination in Treating Patients With Esophageal Cancer
A Phase 1 study testing TTK, LY6K, and IMP-3 peptides in people with Esophageal Cancer, run by University of Yamanashi at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- TTK, LY6K, and IMP-3 peptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2006to Dec 2009
- 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
- DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy
- PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Age≧20 years, 80≦years
- WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
- Patients must be HLA-A2402
- 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)
- Breastfeeding
- Serious bleeding disorder
- Serious infections requiring antibiotics
- Concomitant treatment with steroids or immunosuppressing agent
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
University of Yamanashi, First Department of Surgery
1110 Shimokato, Chuo-city, Yamanashi, 409-3898
Koji Kono, MD, PhD
About this study
Official title: Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
Read the detailed description
We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.
- Conditions
- Esophageal Cancer
- Being tested
- TTK, LY6K, and IMP-3 peptides
- Keywords
- Epitope peptide, CTL, Esophageal cancer, Vaccination
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTK, LY6K, and IMP-3 peptidesBiological
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: TTK, LY6K, and IMP-3 peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (toxicities as assessed by NCI CTCAE version 3)
Measured: 3 months
Secondary outcomes (1)
Immunological and clinical response
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 posted22 May 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yamanashi
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Koji Kono, MD.PhD, Principal investigator, First Depatment of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682227
- Sponsor's protocol ID
- YMU-01
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. doi: 10.1038/sj.onc.1205518.
PubMed 12037668Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.
PubMed 12460921Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.
PubMed 17784873Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.
PubMed 18089789Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.
PubMed 19459850
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00682227
- Acronym / sponsor ID
- YMU-01
- Conditions
- Esophageal Cancer
- Keywords
- Epitope peptide, CTL, Esophageal cancer, Vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of YamanashiUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 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 immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
Detailed description
We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: TTK, LY6K, and IMP-3 peptides |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy
- PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Age≧20 years, 80≦years
- WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
Key exclusion criteria (6 listed)
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breastfeeding
- Serious bleeding disorder
- Serious infections requiring antibiotics
- Concomitant 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 |
|---|---|---|
| TTK, LY6K, and IMP-3 peptidesEach of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round. | Biological | 1 |
Primary outcome
Safety (toxicities as assessed by NCI CTCAE version 3)
Time frame: 3 months
1 secondary outcome
Immunological and clinical response
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 29 May 2008.
- Background: PubMed 12037668Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. doi: 10.1038/sj.onc.1205518.
- Background: PubMed 12460921Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.
- Background: PubMed 17784873Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.
- Background: PubMed 18089789Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.
- Derived from this study: PubMed 19459850Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.
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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.
Koji Kono, MD.PhD principal investigator
First Depatment of 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 TTK, LY6K, and IMP-3 peptides in people with Esophageal Cancer, run by University of Yamanashi 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 6 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 29 May 2008. 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 Koji Kono, M.D. & Ph.D. (+81-55-273-1111 ext. 2337, kojikono@yamanashi.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (toxicities as assessed by NCI CTCAE version 3) (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 NCT00682227, which also lists 5 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 May 2008.