Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Takashi Kimura, Fukushima Medical University

ClinicalTrials.gov Identifier:

NCT00639925

First received: March 7, 2008

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

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, and gemcitabine	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I 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:

Adverse effect, toxicities as assessed by NCI CTCAE version3.0 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Phase I study	Biological: VEGFR1-1084, VEGFR2-169, and gemcitabine One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.

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

1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. 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 aggravated wound
Active or uncontrolled other malignancy
Steroids or immunosuppressing agent dependant 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: NCT00639925

Locations

Japan
Fukushima Medical University Hospital
Fukushima, Japan

Sponsors and Collaborators

Fukushima Medical University

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

Investigators

Study Chair:

Mitsukazu Gotoh, MD, PhD

Fukushima Medical University, First depertment of Surgery

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:	Takashi Kimura, Assistant professor, Fukushima Medical University
ClinicalTrials.gov Identifier:	NCT00639925 History of Changes
Other Study ID Numbers:	FPCR1R2-1
Study First Received:	March 7, 2008
Last Updated:	March 13, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Angiogenesis Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013

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