Clinical trial NCT01267578: Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)
Official title: Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens (STF-II) for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Epitope peptide, CTL, Esophageal cancer, Vaccination
Lead sponsor: University of Yamanashi
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2010-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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:

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 -

Primary outcomes:
measure: overall survival
timeFrame: death from start of treatment
Secondary outcomes:
measure: CTL response
timeFrame: CTL response after 5 round vaccination
measure: DTH response
timeFrame: Skin reaction after 5 round vaccination
measure: Progression free survival
timeFrame: time from start of vaccination until disease progreesion
Other outcomes:
Locations:
city: Chuo
country: Japan
facility: University of Yamanashi, First Department of Surgery
state: Yamanashi
Study officials:
affiliation: University of Yamanashi, First Department of Surgery
name: Koji Kono, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.