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Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer

NCT00624182 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-06-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Peptide vaccine for URLC10

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.

DRUG

Gemcitabine

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Akita University Hospital

    lead OTHER

Principal Investigators

  • Yuzo Yamamoto, MD · Department of Gastroenterological Surgery, Akita University, School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2016-04-30
Completion
2016-12-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624182 on ClinicalTrials.gov