Back to resultsSafety Study of Multiple Peptide Vaccine to Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LY6K, VEGFR1, VEGFR2
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
- WHO performance status of 0 to 2
- Age ≥ 20 years, ≤75 years
- Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
- Expected survival of at least 3 months
- WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 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
- Patients must be HLA-A2402
- Primary lesion of esophageal cancer must express LY6K
- 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 infections requiring antibiotics
- Patient with peptic ulcer disease
- Previous history of intestinal perforation
- bleeding disorders (INR ≥ 1.5)
- Necessity of drug-mediated inhibition with platelet function
- Taking antithrombogenic agents within 10 days
- Serious hypertension
- Previous history of arterial thrombosis or venous thrombosis
- Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
- Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
- Concomitant treatment with steroids or immunosuppressing agent
- Disease to the central nervous system
- Decision of unsuitableness by principal investigator or physician-in-charge
Sites / Locations
- Takuya Takayama M.D.Ph.D
Outcomes
Primary Outcome Measures
Toxicity of multiple peptide vaccinations
Secondary Outcome Measures
Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells
Full Information
NCT ID
NCT00561275
First Posted
November 14, 2007
Last Updated
July 10, 2008
Sponsor
Japanese Foundation for Cancer Research
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
1. Study Identification
Unique Protocol Identification Number
NCT00561275
Brief Title
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
Official Title
Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Japanese Foundation for Cancer Research
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
Detailed Description
LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
LY6K, VEGFR1, VEGFR2
Intervention Description
1 mg/body every two week with GM-CSF, 4 cycles
Primary Outcome Measure Information:
Title
Toxicity of multiple peptide vaccinations
Time Frame
one year
Secondary Outcome Measure Information:
Title
Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
WHO performance status of 0 to 2
Age ≥ 20 years, ≤75 years
Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
Expected survival of at least 3 months
WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 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
Patients must be HLA-A2402
Primary lesion of esophageal cancer must express LY6K
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 infections requiring antibiotics
Patient with peptic ulcer disease
Previous history of intestinal perforation
bleeding disorders (INR ≥ 1.5)
Necessity of drug-mediated inhibition with platelet function
Taking antithrombogenic agents within 10 days
Serious hypertension
Previous history of arterial thrombosis or venous thrombosis
Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
Concomitant treatment with steroids or immunosuppressing agent
Disease to the central nervous system
Decision of unsuitableness by principal investigator or physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takuya Takayama, M.D.Ph.D
Organizational Affiliation
Cancer Institute of Japanese Foundation for Cancer Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Takuya Takayama M.D.Ph.D
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
17020992
Citation
Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
Results Reference
background
PubMed Identifier
15930316
Citation
Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
Results Reference
background
PubMed Identifier
17784873
Citation
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 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.
Results Reference
background
Learn more about this trial
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
We'll reach out to this number within 24 hrs