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HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
VEGFR1, VEGFR2
Gemcitabine
Sponsored by
Fukushima Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, peptide vaccine, VEGFR, gemcitabine

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  • Measurable disease by CT scan
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • laboratory values as follows: 2,000/mm3 < WBC < 15,000/mm3, Platelet count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
  • HLA-A*0201
  • Able and willing to give valid written infromed consent

Exclusion Criteria:

  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Breast-feeder
  • Active or uncontrolled infection
  • Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  • Serious or uncured wound
  • Active or uncontrolled other malignancy
  • Steroids or immunosuppressing agent dependent status
  • Interstitial pneumonia
  • Ileus
  • Decision of unsuitableness by principal investigator or physician-in-charge

Sites / Locations

  • Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 1 study

Arm Description

Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine

Outcomes

Primary Outcome Measures

Toxicities as assessed by NCI-CACAE ver3

Secondary Outcome Measures

Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
CD8 population
Change in level of regulatory T cells
Objective response rate
Feasibility
Survival

Full Information

First Posted
December 23, 2010
Last Updated
December 23, 2010
Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT01266720
Brief Title
HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
Official Title
Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.
Detailed Description
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, peptide vaccine, VEGFR, gemcitabine

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

Arm Title
Phase 1 study
Arm Type
Experimental
Arm Description
Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
Intervention Type
Biological
Intervention Name(s)
VEGFR1, VEGFR2
Other Intervention Name(s)
VEGFR1 and VEGFR2 specific epitope vaccine
Intervention Description
One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.
Primary Outcome Measure Information:
Title
Toxicities as assessed by NCI-CACAE ver3
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
Time Frame
3 months
Title
CD8 population
Time Frame
3 months
Title
Change in level of regulatory T cells
Time Frame
3 months
Title
Objective response rate
Time Frame
1 year
Title
Feasibility
Time Frame
1 year
Title
Survival
Time Frame
1 year

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: locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer Measurable disease by CT scan ECOG performance status 0-2 Life expectancy > 3 months laboratory values as follows: 2,000/mm3 < WBC < 15,000/mm3, Platelet count >75,000/mm3, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl HLA-A*0201 Able and willing to give valid written infromed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breast-feeder Active or uncontrolled infection Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks Serious or uncured wound Active or uncontrolled other malignancy Steroids or immunosuppressing agent dependent status Interstitial pneumonia Ileus Decision of unsuitableness by principal investigator or physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsukazu Gotoh, MD & PhD
Organizational Affiliation
Fukushima Medical University, Department of Regeneration Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
12415261
Citation
Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.
Results Reference
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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
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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
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HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

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