Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
vaccination
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Epitope peptide, CTL, Esophageal 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
- 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 -
Exclusion Criteria:
- 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 -
Sites / Locations
- University of Yamanashi, First Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
peptide vaccination
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
CTL response
DTH response
Progression free survival
Full Information
NCT ID
NCT01267578
First Posted
December 27, 2010
Last Updated
December 27, 2010
Sponsor
University of Yamanashi
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
1. Study Identification
Unique Protocol Identification Number
NCT01267578
Brief Title
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
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Yamanashi
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Epitope peptide, CTL, Esophageal cancer, Vaccination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
peptide vaccination
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
vaccination
Intervention Description
Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides
Primary Outcome Measure Information:
Title
overall survival
Time Frame
death from start of treatment
Secondary Outcome Measure Information:
Title
CTL response
Time Frame
CTL response after 5 round vaccination
Title
DTH response
Time Frame
Skin reaction after 5 round vaccination
Title
Progression free survival
Time Frame
time from start of vaccination until disease progreesion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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 -
Exclusion Criteria:
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koji Kono, PhD, MD
Phone
+81552737390
Email
kojikono@yamanashi.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koji Kono, PhD, MD
Organizational Affiliation
University of Yamanashi, First Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Yamanashi, First Department of Surgery
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
4093898
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Kono, PhD, MD
Phone
+81552737390
Email
kojikono@yamanashi.ac.jp
First Name & Middle Initial & Last Name & Degree
Kousaku Mimura, PhD. MD
12. IPD Sharing Statement
Citations:
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.
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Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)
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