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Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung Cancer

NCT ID: NCT00874588

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase I study

Group Type EXPERIMENTAL

HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Fukushima Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hiroyuki Suzuki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fukushima Medical University

Fukushima, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 17020992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15930316 (View on PubMed)

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. doi: 10.1158/0008-5472.CAN-06-2137.

Reference Type BACKGROUND
PMID: 17079454 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23578144 (View on PubMed)

Other Identifiers

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FVT-L0901

Identifier Type: -

Identifier Source: org_study_id