NCT01950156

Brief Summary

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

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 nonsmall-cell-lung-cancer

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1 nonsmall-cell-lung-cancer

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

September 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

7.5 years

First QC Date

September 17, 2013

Last Update Submit

March 15, 2019

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

  • Evaluation of safety: the number of adverse events of vaccination therapy.

    2 months

  • Evaluation of clinical efficacy: Progression free survival.

    2 months

  • Evaluation of clinical efficacy: Tumor markers.

    2 months

  • Evaluation of clinical efficacy: Overall survival.

    2 months

  • Evaluation of clinical efficacy: Objective response rate.

    2 months

Secondary Outcomes (1)

  • Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels

    2 months

Study Arms (1)

Vaccine

EXPERIMENTAL

HLA-A\*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Interventions

HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvantBIOLOGICAL

Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A\*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.

Vaccine

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease.
  • ECOG performance status 0-2
  • Age between 20 to 85
  • Clinical efficacy can be evaluated by some methods
  • No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
  • Life expectancy \> 3 months
  • Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
  • HLA-A\*2402
  • Able and willing to give valid written informed consent

You may not qualify if:

  • Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
  • Myocardial infarction within six months before entry
  • Breastfeeding and Pregnancy (woman of child bearing potential)
  • Active and uncontrolled infectious disease
  • Concurrent treatment with steroids or immunosuppressing agent
  • Other malignancy requiring treatment
  • Non-cured traumatic wound
  • Decision of unsuitableness by principal investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Related Publications (7)

  • Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.

    PMID: 19459850BACKGROUND

  • Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823.

    PMID: 18770861BACKGROUND

  • Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30.

    PMID: 18452554BACKGROUND

  • Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24.

    PMID: 18297458BACKGROUND

  • Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.

    PMID: 18089789BACKGROUND

  • Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.

    PMID: 17784873BACKGROUND

  • 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

NUF2 protein, humanAdjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

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

September 17, 2013

First Posted

September 25, 2013

Study Start

September 1, 2011

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

JP(1)