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

Study Overview

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

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.

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.

Pancreatic Cancer

BIOLOGICAL: VEGFR1, VEGFR2
DRUG: Gemcitabine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-12-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-12-23
First Submitted that Met QC Criteria 2010-12-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-12-24
First Posted (ESTIMATED) 2010-12-24	Results First Posted N/A	Last Verified 2010-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1 study Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine	BIOLOGICAL: VEGFR1, VEGFR2 One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22 DRUG: Gemcitabine Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase 1 study

Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine

BIOLOGICAL: VEGFR1, VEGFR2

One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

DRUG: Gemcitabine

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Primary Outcome Measures	Measure Description	Time Frame
Toxicities as assessed by NCI-CACAE ver3		3 months

Secondary Outcome Measures	Measure Description	Time Frame
Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration		3 months
CD8 population		3 months
Change in level of regulatory T cells		3 months
Objective response rate		1 year
Feasibility		1 year
Survival		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

STUDY_CHAIR: Mitsukazu Gotoh, MD & PhD, Fukushima Medical University, Department of Regeneration Surgery

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.

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Patients

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Clinical Trial Record