Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2) - Full Text View

Purpose

The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Condition	Intervention	Phase
Pancreatic Cancer	Biological: VEGFR1-1084, VEGFR2-169, Gemcitabine	Phase I Phase II

MedlinePlus related topics:

Cancer Pancreatic Cancer

ChemIDplus related topics:

Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase Ｉ/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer

Further study details as provided by Fukushima Medical University:

Primary Outcome Measures:

toxicities as assessed by NCI-CACAE ver3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration [ Time Frame: 3months ] [ Designated as safety issue: No ]
CD8 population [ Time Frame: 3months ] [ Designated as safety issue: No ]
Change in level of regulatory T cells [ Time Frame: 3months ] [ Designated as safety issue: No ]
Objective response rate [ Time Frame: 1year ] [ Designated as safety issue: No ]
feasibility [ Time Frame: 1year ] [ Designated as safety issue: No ]
Survival [ Time Frame: 1year ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 1/2 study: Experimental	Biological: VEGFR1-1084, VEGFR2-169, Gemcitabine One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Detailed Description:

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS

Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
Measurable disease by CT scan

PATIENTS CHARACTERISTICS

ECOG performance status 0-2
Life expectancy > 3 months
Laboratory values as follows:
- 2,000/mm3 < WBC < 15000/mm3
- Platelet count ≥ 750,000/mm³
- Total Bilirubin ≤ 1.5 x
- Aspartate transaminase < 150 IU/L
- Alanine transaminase < 150 IU/L
- Creatinine ≤ 3.0 mg/dl
HLA-A*2402
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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655785

Contacts


Contact: Takashi Kimura, MD/PhD	81-24-547-1254	tkimura@fmu.ac.jp

Locations


Japan
	Fukushima Medical University Hospital	Recruiting
	Fukushima, Japan, 960-1295
	Contact: Takashi Kimura, MD/PhD 81-24-547-1254 tkimura@fmu.ac.jp

Sponsors and Collaborators

Fukushima Medical University

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

Investigators


Study Chair:	Mitsukazu Gotoh, M.D. & Ph.D	Fukushima Medical University, Department

More Information

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. 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.

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.

Responsible Party:	Fukushima Medical University ( Department of Surgery I )
Study ID Numbers:	FPCR1R2-2
First Received:	April 4, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00655785
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Fukushima Medical University:

Epitope peptide

CTL

Pancreatic cancer

Vaccination VEGFR1

VEGFR2

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Gemcitabine

Recurrence

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Fukushima Medical University Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Fukushima Medical University
ClinicalTrials.gov Identifier:	NCT00655785