Esophageal CancerPhase 1/2NCT00681330
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer
A Phase 1/2 study testing URC10, TTK, KOC1 in people with Esophageal 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*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- URC10, TTK, KOC1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- May 2008to Apr 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 esophageal cancer
- Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
- ECOG performance status 0-2
- Life expectancy > 3 months
- HLA-A*2402
- 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
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
- Uncontrolled brain and/or intraspinal metastasis
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
Japan1 site
The Institutute of Medical Science, University of Tokyo
4-6-1, Shirokanedai, 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*2402 in Treating Patients With Refractory Esophageal Cancer
The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
Read the detailed description
URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in human esophageal tumors. We identified that peptides derived from these proteins 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, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of 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 vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.
- Conditions
- Esophageal Cancer
- Being tested
- URC10, TTK, KOC1
- Keywords
- Peptide Vaccine, URLC10, TTK, KOC1
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URC10, TTK, KOC1Biological
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Biological: URC10, TTK, KOC1 |
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: Two months
Secondary outcomes (1)
To evaluate immunological responses
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
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, The Institutute of Medical Science, University of Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681330
- Sponsor's protocol ID
- IMS-OKA2402
- Status last verified
- Nov 2009
- First submitted
- 19 May 2008
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.
PubMed 11280777Wada 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 15930316Hasegawa 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 12460921Lin 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 12037668
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 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*2402 in Treating Patients With Refractory Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00681330
- Acronym / sponsor ID
- IMS-OKA2402
- Conditions
- Esophageal Cancer
- Keywords
- Peptide Vaccine, URLC10, TTK, KOC1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- 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 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 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*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
Detailed description
URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in human esophageal tumors. We identified that peptides derived from these proteins 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, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of 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 vaccines. 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: URC10, TTK, KOC1 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced or recurrent esophageal cancer
- Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
- ECOG performance status 0-2
- Life expectancy > 3 months
- HLA-A*2402
Key exclusion criteria (7 listed)
- Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
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 |
|---|---|---|
| URC10, TTK, KOC1Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK 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: Two months
1 secondary outcome
To evaluate immunological responses
Time frame: Two 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 Nov 2009.
- Background: PubMed 11280777Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.
- 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.
- 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 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.
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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
The Institutute of Medical Science, University of Tokyo
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 URC10, TTK, KOC1 in people with Esophageal 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 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: finished, as of the sponsor's last update on 19 Nov 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 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?
Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) (time frame: Two 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 NCT00681330, which also lists 4 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 19 Nov 2009.