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

Sponsors and Collaborators:	Tokyo University Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Tokyo University
ClinicalTrials.gov Identifier:	NCT00683358

Purpose

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).

Condition	Intervention	Phase
Pancreatic Cancer Pancreas Neoplasms	Biological: VEGFR1-A24-1084 (SYGVLLWEI)	Phase I Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Montanide ISA 51

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer

Further study details as provided by Tokyo University:

Primary Outcome Measures:

PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Tumor regression(Imaging study, tumor marker, etc.) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683358

Locations

Japan, Tokyo
Research Hospital, The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan, 108-8639

Sponsors and Collaborators

Tokyo University

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

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.

Responsible Party:	Research Hospital, Institute of Medical Science, The University of Tokyo ( Naohide Yamashita MD, PhD )
Study ID Numbers:	IMSUT-PPKVEGFR12402
Study First Received:	May 16, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00683358 History of Changes
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Tokyo University:

cancer
pancreas
advanced
peptide
vaccination
VEGFR1

HLA
gemcitabine
IFA
Cancer of Pancreas
Neoplasms, Pancreatic
Pancreas Cancer

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Endothelial Growth Factors
Immunosuppressive Agents
Antiviral Agents
Pancrelipase

Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Mitogens
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009