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CompletedNCT00633724Updated Aug 15, 2013

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

A Phase 1 interventional study of HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 in Non Small Cell Lung Cancer, sponsored by Fukushima Medical University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.

Sponsored by Fukushima Medical University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non Small Cell Lung Cancer
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    1

    Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2

Interventions

  • BiologicalHLA-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.

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Peptides specific CTL responses in vitro

    Time frame: 3 months

  2. Objective response rate as assessed using RECIST criteria

    Time frame: 6 months

  3. Changes in levels of regulatory T cells

    Time frame: 3 months

06

Study locations

1 site
  • Fukushima Medical University Hospital
    Fukushima, Fuskushima 960-1295, Japan
07

References and documents

Publications

  • 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. PubMed 16630140 ↗
  • 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. PubMed 15623641 ↗
  • 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. PubMed 17020992 ↗
  • 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. PubMed 15930316 ↗
  • 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. PubMed 16108831 ↗
  • 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. PubMed 23578144 ↗
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Registry details

Key details

Study ID
NCT00633724
Lead sponsor
Fukushima Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
Responsible party
Hiroyuki Suzuki (Professor, Fukushima Medical University) — Principal investigator
First posted
Mar 12, 2008
Start date
May 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Aug 15, 2013

Study contacts

Mitsukazu Gotoh, MD,PhD
study chair · Fukushima Medical University, First department of Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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