NCT00674258

Brief Summary

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

May 5, 2008

Last Update Submit

May 12, 2008

Conditions

Non Small Cell Lung Cancer

Keywords

HLA-A*2402Peptide VaccineURLC10TTKKOC1

Outcome Measures

Primary Outcomes (1)

  • safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)

    two months

Secondary Outcomes (1)

  • To evaluate immunological responses

    two months

Study Arms (1)

B

EXPERIMENTAL
Biological: URLC10, TTK and KOC1

Interventions

URLC10, TTK and KOC1BIOLOGICAL

Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), TTK- peptide(1mg) and KOC1- peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

B

Eligibility Criteria

Age20 Years - 85 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
  • /mm3\<WBC\<15000/mm3
  • Platelet count\>100000/mm3
  • Bilirubin \< 3.0mg/dl
  • Asparate transaminase \< 150IU/L
  • Alanine transaminase \< 150IU/L
  • Creatinine \< 3.0mg/dl
  • Able and willing to give valid written informed consent

You may not qualify if:

  • Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  • Uncontrolled brain and/or intraspinal metastasis
  • Decision of unsuitableness by principal investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Institute of Medical Science, The University of Tokyo

Tokyo, Tokyo, 108-8639, Japan

RECRUITING

Related Publications (5)

  • 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

  • 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

  • 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.

    PMID: 16630140BACKGROUND

  • Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321.

    PMID: 9500606BACKGROUND

  • 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

LY6K protein, human

Condition Hierarchy (Ancestors)

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

Study Officials

  • Naohide Yamashita, MD/PhD

    Tokyo University

    STUDY CHAIR

Central Study Contacts

Takeshi Fujii, MD/PhD

CONTACT

81-3-3443-8111tmks@ims.u-tokyo.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

JP(1)