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Status unknownNCT01267578Updated Dec 28, 2010

Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)

A Phase 2 interventional study of vaccination in Esophageal Cancer, sponsored by University of Yamanashi. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-12-28.

Sponsored by University of Yamanashi · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Read the detailed description

The phase II multicenter trial of vaccination study using peptides derived from URLC10, CDCA1, and KOC1 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy are performed to evaluate the survival benefit of the cancer vaccination.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Epitope peptide, CTL, Esophageal cancer, Vaccination
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University of Yamanashi is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS

  1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

  1. ECOG performance status 0-2
  2. Age≧20 years, 80≦years
  3. 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
  4. No therapy 4 weeks prior to the initiation of the trial
  5. Able and willing to give valid written informed consent -

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Serious bleeding disorder
  4. Serious infections requiring antibiotics
  5. Concomitant treatment with steroids or immunosuppressing agent
  6. Decision of unsuitableness by principal investigator or physician-in-charge -
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    peptide vaccination

    Biological: vaccination

Interventions

  • Biologicalvaccination

    Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

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What researchers measure

Primary outcomes

  1. overall survival

    Time frame: death from start of treatment

Secondary outcomes

  1. CTL response

    Time frame: CTL response after 5 round vaccination

  2. DTH response

    Time frame: Skin reaction after 5 round vaccination

  3. Progression free survival

    Time frame: time from start of vaccination until disease progreesion

07

Study locations

1 of 1 sites recruiting
  • University of Yamanashi, First Department of Surgery
    Chuo, Yamanashi 4093898, Japan
    Recruiting
08

References and documents

Publications

  • 1. Okabe H, Satoh S, Kato T, et al. 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; 61: 2129-37. 2 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; 21: 4120-28. 3. Hasegawa S, Furukawa Y, Li M, et al. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res 2002; 62: 7012-17. 4. 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; 98: 1803-8. 5. Ishikawa N, Takano A, Yasui W, et al. 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; 67: 11601-11. 6. Yoshiki Mizukami, Koji Kono, Yataro Daigo, et al. Detection of novel Cancer-Testis antigen-specific T-cell responses in TIL, regional lymph nodes and PBL in patients with esophageal squamous cell carcinoma. Cancer Science 2008 ;99:1448-54 6. Koji Kono, Yoshiki Mizukami, Yataro Daigo, Atsushi Takano, Ken Masuda, Koji Yoshida, Takuya Tsunoda, Yoshihiko Kawaguchi, Yusuke Nakamura, and Hideki Fujii. 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;100:1502-9.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01267578
Lead sponsor
University of Yamanashi
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
First posted
Dec 28, 2010
Start date
Apr 2010
Primary completion
May 2011 (estimated)
Completion
May 2012 (estimated)
Last update
Dec 28, 2010

Study contacts

Koji Kono, PhD, MD
Contact
kojikono@yamanashi.ac.jp
+81552737390
Koji Kono, PhD, MD
principal investigator · University of Yamanashi, First Department of Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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