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Esophageal CancerPhase 1/2NCT00669292

PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer

A Phase 1/2 study testing URLC10-177, TTK-567, CpG-7909 in people with Esophageal Cancer, run by Wakayama Medical University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer. 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?
URLC10-177, TTK-567, CpG-7909
How many people
29 participants
Where
1 siteJapan
Study dates
Nov 2006to Nov 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DISEASE CHARACTERISTICS
  • locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer
  • measurable disease by CT scan
  • PATIENT CHARACTERISTICS
  • ECOG performance status 0-1
  • Life expectancy > 3 months
Show all 14Show fewer
  • Laboratory values as follows
  • 2000/mm3 < WBC < 15000/mm3
  • Platelet count > 75000/mm3
  • Aspartate transaminase < 150 IU/L
  • Alanine transaminase < 150 IU/L
  • Creatinine < 2.0 mg/dl
  • HLA-A*2402
  • 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, or immunotherapy within 4 weeks
  • Clinically significant heart disease
  • Decision of unsuitableness by principal investigator or physician-in-charge

Trial locations and contacts

1 site in 1 country.

Makoto Iwahashi, MD contact

81-73-441-0613

makoto@wakayama-med.ac.jp

Japan1 site, 1 recruiting

  • Wakayama Medical University Hospital

    811-1 Kimiidera, Wakayama, Wakayama

    Makoto Iwahashi, MD, 81-73-441-0613, makoto@wakayama-med.ac.jp

    Makoto Iwahashi, MD

    Recruiting

Other trials in Japan

About this study

Official title: Phase I/II Study of URLC10-177 and TTK-567, Novel Tumor Specific Epitope Peptides Restricted to HLA-A*2402 Derived From Tumor Associated Antigens, Combined With CpG7909, a TLR9 Agonist, in Patients With Advanced or Recurrent Esophageal Cancer.

This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer.

Read the detailed description

phase I: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (escalating doses: 0, 0.02, 0.1mg/kg) emulsified 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, or for maximum 2 cycles, whichever occurs first. In this phase I study, we evaluate the safety and tolerability of URLC10-177, TTK-567 and different doses of CpG7909 to determine the recommended phase II dose of CpG7909.

phase II: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (recommended dose determined in phase I study) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered for 2 cycles. In this phase II study, we evaluate the efficacy of this vaccine therapy.

Being tested
URLC10-177, TTK-567, CpG-7909
Keywords
esophageal cancer, peptide, URLC10, TTK, CpG7909
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • URLC10-177, TTK-567, CpG-7909Biological

    peptide, peptide, TLR-9 agonist

What is being measured

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

  1. Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)

    Measured: 2 months

Secondary outcomes (6)

  1. To evaluate immunological responses (Phase I/II)

    Measured: 2months

  2. To determine the recommended phase II dose of CpG7909(Phase I)

    Measured: 2months

  3. To determine the clinical effectiveness in the patients with measurable disease(Phase I)

    Measured: 2months

  4. To analyze the toxicity(Phase II)

    Measured: 2months

  5. Time to progression(Phase II)

    Measured: 5 years

  6. survival(Phase II)

    Measured: 5 years

Timeline

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

  1. First posted30 Apr 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2009 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669292
Sponsor's protocol ID
WEUTC
Status last verified
Sep 2010
First submitted
28 Apr 2008
Last updated
9 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Iwahashi M, Katsuda M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Yamaue H. Vaccination with peptides derived from cancer-testis antigens in combination with CpG-7909 elicits strong specific CD8+ T cell response in patients with metastatic esophageal squamous cell carcinoma. Cancer Sci. 2010 Dec;101(12):2510-7. doi: 10.1111/j.1349-7006.2010.01732.x. Epub 2010 Sep 28.

    PubMed 20874827

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing URLC10-177, TTK-567, CpG-7909 in people with Esophageal Cancer, run by Wakayama 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 14 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 9 Sep 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Makoto Iwahashi, MD (81-73-441-0613, makoto@wakayama-med.ac.jp), or a site near the patient. 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 NCT00669292, which also lists 1 linked publication.

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 9 Sep 2010; AzTrials last refreshed its copy on 7 Nov 2026.

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