A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

NCT00995358 | Unknown Phase 2 DMC

• 1 other identifier: YMU-02
• 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 for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Conditions

Esophageal Cancer

Keywords

Epitope peptide; CTL; Esophageal cancer; Vaccination

Outcome Measures

Primary Outcomes (1)

• Overall survival after the 1st vaccination

  2 years

Secondary Outcomes (3)

• Antigen specific control response induced by vaccination

  1 year

• DTH response induced by vaccination

  1 year

• Time to progression after the 1st vaccination

  1 year

Study Arms (1)

vaccination

EXPERIMENTAL

Biological: peptide

Interventions

peptide BIOLOGICAL

Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

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≦ 80years
• 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)

First Department of Surgery, University of Yamanashi

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

Related Publications (2)

• 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.

  RESULT

• Kono K, Iinuma H, Akutsu Y, Tanaka H, Hayashi N, Uchikado Y, Noguchi T, Fujii H, Okinaka K, Fukushima R, Matsubara H, Ohira M, Baba H, Natsugoe S, Kitano S, Takeda K, Yoshida K, Tsunoda T, Nakamura Y. Multicenter, phase II clinical trial of cancer vaccination for advanced esophageal cancer with three peptides derived from novel cancer-testis antigens. J Transl Med. 2012 Jul 9;10:141. doi: 10.1186/1479-5876-10-141.

  PMID: 22776426 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Peptides

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)

Amino Acids, Peptides, and Proteins

Study Officials

• Koji Kono, MD.PhD

  University of Yamanashi, First Deparment of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koji Kono, MD,PhD

CONTACT

+81-55-273-1111; 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: October 8, 2009
• First Posted: October 15, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: October 15, 2009

Record last verified: 2009-10

Locations

JP (1)