NCT00624182

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immune response of different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with gemcitabine. Recommended phase II dose will be also determined.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

February 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

8.2 years

First QC Date

February 19, 2008

Last Update Submit

June 22, 2015

Conditions

Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety (toxicities as assessed by NCI CTCAE version 3)

    5 years

Secondary Outcomes (6)

  • URLC10 peptide specific CTL induction

    5 years

  • DTH to URLC10 peptide

    5 years

  • Changes in levels of regulatory T cells

    5 years

  • Objective response rate as assessed by RECIST criteria

    5 years

  • Time to progression

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Phase I study

EXPERIMENTAL
Biological: Peptide vaccine for URLC10Drug: Gemcitabine

Interventions

Peptide vaccine for URLC10BIOLOGICAL

Increasing the doses of URLC10 peptides will be administered by subcutaneous injection on day 1, 8, 15, and 22 of each 28-day treatment cycles. Doses of 0.5, 1.0, 2.0mg/body are planned. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.

Also known as: Gemcitabine
Phase I study
GemcitabineDRUG

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, and 15. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.

Phase I study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS
  • Advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer
  • measurable disease by CT scan, ultrasonography, or other imaging modalities.
  • PATIENTS CHARACTERISTICS
  • ECOG performance status 0-2
  • Life expectancy \>3 months
  • Laboratory values as follows 2,000/mm³\< WBC \< 15,000/mm³ Platelet count ≥ 75,000/mm³ Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
  • HLA-A\*2402 or HLA-A\*0201
  • Able and willing to give valid written informed consent

You may not qualify if:

  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Serious or uncontrolled infection
  • Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks.
  • Other malignancy within 5 years prior to entry into the study
  • Concomitant treatment with steroids or immunosuppressing agent
  • Disease to the central nervous system
  • Decision of unsuitableness by principal investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akita University Hosipital

Akita, Akita, 010-8543, Japan

Location

Related Publications (7)

  • Date Y, Kimura A, Kato H, Sasazuki T. DNA typing of the HLA-A gene: population study and identification of four new alleles in Japanese. Tissue Antigens. 1996 Feb;47(2):93-101. doi: 10.1111/j.1399-0039.1996.tb02520.x.

    PMID: 8851721BACKGROUND

  • Dauer M, Herten J, Bauer C, Renner F, Schad K, Schnurr M, Endres S, Eigler A. Chemosensitization of pancreatic carcinoma cells to enhance T cell-mediated cytotoxicity induced by tumor lysate-pulsed dendritic cells. J Immunother. 2005 Jul-Aug;28(4):332-42. doi: 10.1097/01.cji.0000164038.41104.f5.

    PMID: 16000951BACKGROUND

  • Correale P, Cusi MG, Del Vecchio MT, Aquino A, Prete SP, Tsang KY, Micheli L, Nencini C, La Placa M, Montagnani F, Terrosi C, Caraglia M, Formica V, Giorgi G, Bonmassar E, Francini G. Dendritic cell-mediated cross-presentation of antigens derived from colon carcinoma cells exposed to a highly cytotoxic multidrug regimen with gemcitabine, oxaliplatin, 5-fluorouracil, and leucovorin, elicits a powerful human antigen-specific CTL response with antitumor activity in vitro. J Immunol. 2005 Jul 15;175(2):820-8. doi: 10.4049/jimmunol.175.2.820.

    PMID: 16002679BACKGROUND

  • 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

  • Obama K, Ura K, Li M, Katagiri T, Tsunoda T, Nomura A, Satoh S, Nakamura Y, Furukawa Y. Genome-wide analysis of gene expression in human intrahepatic cholangiocarcinoma. Hepatology. 2005 Jun;41(6):1339-48. doi: 10.1002/hep.20718.

    PMID: 15880566BACKGROUND

  • Marchand M, van Baren N, Weynants P, Brichard V, Dreno B, Tessier MH, Rankin E, Parmiani G, Arienti F, Humblet Y, Bourlond A, Vanwijck R, Lienard D, Beauduin M, Dietrich PY, Russo V, Kerger J, Masucci G, Jager E, De Greve J, Atzpodien J, Brasseur F, Coulie PG, van der Bruggen P, Boon T. Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer. 1999 Jan 18;80(2):219-30. doi: 10.1002/(sici)1097-0215(19990118)80:23.0.co;2-s.

    PMID: 9935203BACKGROUND

  • 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

MeSH Terms

Conditions

Bile Duct Neoplasms

Interventions

Protein Subunit VaccinesLY6K protein, humanGemcitabine

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex MixturesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yuzo Yamamoto, MD

    Department of Gastroenterological Surgery, Akita University, School of Medicine

    STUDY CHAIR

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
Gastroenterological Surgery

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 26, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

JP(1)