AzTrials
AzTrials

Esophageal CancerPhase 1NCT00561275

Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

A Phase 1 study testing LY6K, VEGFR1, VEGFR2 in people with Esophageal Cancer, run by Japanese Foundation for Cancer Research at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
LY6K, VEGFR1, VEGFR2
How many people
6 participants
Where
1 siteJapan
Study dates
Oct 2007to Jun 2008
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
  • WHO performance status of 0 to 2
  • Age ≥ 20 years, ≤75 years
  • Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
  • Expected survival of at least 3 months
  • WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 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
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  • Patients must be HLA-A2402
  • Primary lesion of esophageal cancer must express LY6K
  • 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 infections requiring antibiotics
  • Patient with peptic ulcer disease
  • Previous history of intestinal perforation
  • bleeding disorders (INR ≥ 1.5)
Show all 15Show fewer
  • Necessity of drug-mediated inhibition with platelet function
  • Taking antithrombogenic agents within 10 days
  • Serious hypertension
  • Previous history of arterial thrombosis or venous thrombosis
  • Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
  • Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
  • Concomitant treatment with steroids or immunosuppressing agent
  • Disease to the central nervous system
  • Decision of unsuitableness by principal investigator or physician-in-charge

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Takuya Takayama M.D.Ph.D

    Tokyo, 135-8550

Other trials in Japan

About this study

Official title: Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer

This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.

Read the detailed description

LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.

Being tested
LY6K, VEGFR1, VEGFR2
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY6K, VEGFR1, VEGFR2Biological

    1 mg/body every two week with GM-CSF, 4 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity of multiple peptide vaccinations

    Measured: one year

Secondary outcomes (1)

  1. Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2008
  4. Study completionJun 2008

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561275
Sponsor's protocol ID
TB-454
Status last verified
Jul 2008
First submitted
14 Nov 2007
Last updated
15 Jul 2008
Results posted
No
Data monitoring committee
No

Publications

  • Ishizaki 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 17020992

  • Wada 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

  • Suda 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 17784873

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY6K, VEGFR1, VEGFR2 in people with Esophageal Cancer, run by Japanese Foundation for Cancer Research 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 15 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 15 Jul 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?

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?

Toxicity of multiple peptide vaccinations (time frame: one year). 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 NCT00561275, 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 15 Jul 2008.

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