NCT00874588

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, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

3.3 years

First QC Date

April 1, 2009

Last Update Submit

August 13, 2013

Conditions

Non Small Cell Lung Cancer

Outcome Measures

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

    3 months

Secondary Outcomes (3)

  • Peptides specific CTL responses in vitro

    3 months

  • Objective response rate as assessed using RECIST criteria

    6 months

  • Changes in levels of regulatory T cells

    3 months

Study Arms (1)

Phase I study

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

Interventions

HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2BIOLOGICAL

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.

Phase I study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukushima Medical University

Fukushima, 960-1295, Japan

Location

Related Publications (4)

  • 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.

    PMID: 17020992BACKGROUND

  • 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.

    PMID: 15930316BACKGROUND

  • 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.

    PMID: 17079454BACKGROUND

  • 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.

    PMID: 23578144DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

NUF2 protein, humanReceptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

JP(1)