Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination For Advanced Pancreatic Cancer

Study Overview

Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively. HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood. These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Pancreatic Cancer
Pancreas Neoplasms

BIOLOGICAL: VEGFR1-A24-1084 (SYGVLLWEI)

IMSUT-PPKVEGFR12402

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 2008-05-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-05-06
First Submitted that Met QC Criteria 2008-05-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-05-07
First Posted (ESTIMATED) 2008-05-23	Results First Posted N/A	Last Verified 2009-01

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1	BIOLOGICAL: VEGFR1-A24-1084 (SYGVLLWEI) HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6t

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

BIOLOGICAL: VEGFR1-A24-1084 (SYGVLLWEI)

HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6t

Primary Outcome Measures	Measure Description	Time Frame
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)		1 year

Secondary Outcome Measures	Measure Description	Time Frame
Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)		1 year
Tumor regression(Imaging study, tumor marker, etc.)		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:

Heterozygote or homozygote of HLA-A*2402 allele
Inoperable or recurrent pancreatic cancer with or without any prior therapy
Difficult to continue the prior therapy due to treatment-related toxicities
ECOG performance status 0-2
Evaluable primary or metastatic lesion with RECIST criteria
Clearance period from prior therapy more than 4 weeks
Life expectancy more than 3 months
Laboratory values as follows 2,000/μL100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl

Pregnancy (refusal or inability to use effective contraceptives)
Breastfeeding
Active or uncontrolled infection
Systemic use of corticosteroids or immunosuppressants
Uncontrollable brain metastasis and/or meningeal infiltration
Unhealed external wound
Possibilities of complicated paralytic ileus or interstitial pneumonitis
Decision of not eligible determined by principal investigator or attending doctor

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_DIRECTOR: Naohide Yamashita, MD, PhD, Director, Research Hospital, Institute of Medical Science, Tokyo University

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

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.
Nagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011.

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