Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-Angiogenic Peptide Antigen in Treating Patients With Non-Small Cell Lung Cancer - 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:	NCT00874588

Purpose

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Biological: HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase I Trial in Studying Peptide Vaccine Therapy Targeting to Cancer Specific Antigen Combined With Anti-Angiogenic Peptide Antigen in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Fukushima Medical University:

Primary Outcome Measures:

Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Peptides specific CTL responses in vitro [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Objective response rate as assessed using RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes in levels of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	March 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase I study: Experimental	Biological: HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2 Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 1.0mg and 3.0mg.

Detailed Description:

URLC10 and CDCA1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 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 vivo.

According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Disease characteristics

Advanced or recurrent non small cell lung cancer
Second line or later therapeutic status

Patient characteristics

ECOG performance status 0-2
Life expectancy > 3 months
HLA-A*2402
Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl
Able and willing to give valid written informed consent

Exclusion Criteria:

Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
Pregnancy (woman of child bearing potential)
Active and uncontrolled infectious disease
Adrenal cortical steroid hormone dependent status
Decision of unsuitableness by principal investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874588

Contacts

Contact: Hiroyuki Suzuki, MD	+81-24-547-1253	hiro@fmu.ac.jp
Contact: Reiko Satoh	+81-24-547-1253	reisa9@fmu.ac.jp

Locations

Japan
Fukushima Medical University	Recruiting
Fukushima, Japan, 960-1295
Contact: Hiroyuki Suzuki, MD +81-24-547-1253 hiro@fmu.ac.jp
Contact: Reiko Satoh +81-24-547-1253 reisa9@fmu.ac.jp
Principal Investigator: Hiroyuki Suzuki, MD

Sponsors and Collaborators

Fukushima Medical University

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

More Information

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.

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.

Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48.

Responsible Party:	Fukushima Medical University ( Department of Surgery, division of General Thoracic Surgery )
Study ID Numbers:	FVT-L0901
Study First Received:	April 1, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00874588 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Angiogenesis Inhibitors
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009