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

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

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 Drug: Gemcitabine	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 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 Drug: Gemcitabine 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

Locations

Japan
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295

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
Study First Received:	April 4, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00655785 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Antiviral Agents

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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine

Endocrine Gland Neoplasms
Digestive System Neoplasms
Growth Substances
Endocrine System Diseases
Enzyme Inhibitors
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases

ClinicalTrials.gov processed this record on September 09, 2009