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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
Sponsored by
Fukushima Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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

Secondary Outcome Measures

Peptides specific CTL responses in vitro
Objective response rate as assessed using RECIST criteria
Changes in levels of regulatory T cells

Full Information

First Posted
February 20, 2008
Last Updated
August 13, 2013
Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00633724
Brief Title
Multiple-Vaccine Therapy in Treating Patients With Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Peptides specific CTL responses in vitro
Time Frame
3 months
Title
Objective response rate as assessed using RECIST criteria
Time Frame
6 months
Title
Changes in levels of regulatory T cells
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsukazu Gotoh, MD,PhD
Organizational Affiliation
Fukushima Medical University, First department of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Fukushima Medical University Hospital
City
Fukushima
State/Province
Fuskushima
ZIP/Postal Code
960-1295
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
16630140
Citation
Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.
Results Reference
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PubMed Identifier
15623641
Citation
Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.
Results Reference
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PubMed Identifier
17020992
Citation
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. doi: 10.1158/1078-0432.CCR-06-0750.
Results Reference
background
PubMed Identifier
15930316
Citation
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. doi: 10.1158/0008-5472.CAN-04-3759.
Results Reference
background
PubMed Identifier
16108831
Citation
Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x.
Results Reference
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PubMed Identifier
23578144
Citation
Suzuki H, Fukuhara M, Yamaura T, Mutoh S, Okabe N, Yaginuma H, Hasegawa T, Yonechi A, Osugi J, Hoshino M, Kimura T, Higuchi M, Shio Y, Ise K, Takeda K, Gotoh M. Multiple therapeutic peptide vaccines consisting of combined novel cancer testis antigens and anti-angiogenic peptides for patients with non-small cell lung cancer. J Transl Med. 2013 Apr 11;11:97. doi: 10.1186/1479-5876-11-97.
Results Reference
derived

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

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