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Multiple-Vaccine Therapy in Treating Patients With Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633724
First Posted: March 12, 2008
Last Update Posted: August 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Hiroyuki Suzuki, Fukushima Medical University
  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, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Condition Intervention Phase
Non Small Cell Lung Cancer Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Multiple-vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hiroyuki Suzuki, 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 ]

Secondary Outcome Measures:
  • Peptides specific CTL responses in vitro [ Time Frame: 3 months ]
  • Objective response rate as assessed using RECIST criteria [ Time Frame: 6 months ]
  • Changes in levels of regulatory T cells [ Time Frame: 3 months ]

Estimated Enrollment: 9
Study Start Date: May 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: HLA-A*2402restricted URLC10, TTK, 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 0.5mg, 1.0mg and 3.0mg.

Detailed Description:
URLC10 and TTK 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Disease characteristics

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

Patient characteristics

  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. HLA-A*2402
  4. 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
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
  2. Pregnancy (woman of child bearing potential)
  3. Active and uncontrolled infectious disease
  4. Adrenal cortical steroid hormone dependent status
  5. Decision of unsuitableness by principal investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633724


Locations
Japan
Fukushima Medical University Hospital
Fukushima, Fuskushima, Japan, 960-1295
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 department of Surgery
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroyuki Suzuki, Professor, Fukushima Medical University
ClinicalTrials.gov Identifier: NCT00633724     History of Changes
Other Study ID Numbers: FVT-L0701
First Submitted: February 20, 2008
First Posted: March 12, 2008
Last Update Posted: August 15, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms