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

NCT01267578 | Unknown Phase 2 DMC

• 1 other identifier: YMU-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Esophageal Cancer

Keywords

Epitope peptide, CTL, Esophageal cancer, Vaccination

Outcome Measures

Primary Outcomes (1)

• overall survival

  death from start of treatment

Secondary Outcomes (3)

• CTL response

  CTL response after 5 round vaccination

• DTH response

  Skin reaction after 5 round vaccination

• Progression free survival

  time from start of vaccination until disease progreesion

Study Arms (1)

peptide vaccination

EXPERIMENTAL

Biological: vaccination

Interventions

vaccination BIOLOGICAL

Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

peptide vaccination

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISEASE CHARACTERISTICS
• \. 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
• No therapy 4 weeks prior to the initiation of the trial
• Able and willing to give valid written informed consent -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Yamanashi: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

University of Yamanashi, First Department of Surgery

Chūō, Yamanashi, 4093898, Japan

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Koji Kono, PhD, MD

  University of Yamanashi, First Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koji Kono, PhD, MD

CONTACT

+81552737390; kojikono@yamanashi.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

JP (1)