We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259505
First Posted: December 14, 2010
Last Update Posted: November 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tokyo University
Saint Luca International Hospital
Information provided by (Responsible Party):
Minoru Fujimori, Tokyo Medical University
  Purpose
The purpose of this study is to evaluate the safety of HLA-A*2402 restricted epitope peptides CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.

Condition Intervention Phase
Metastatic Breast Cancer Biological: CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer

Resource links provided by NLM:


Further study details as provided by Minoru Fujimori, Tokyo Medical University:

Primary Outcome Measures:
  • safety (Phase I: toxicities as assessed by NCI CTCAE version3) [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • to evaluate efficacy (feasibility as evaluated by RECIST) [ Time Frame: 2 months ]
    to evaluate overall survival to evaluate progression free survivial to evaluate efficacy (feasibility as evaluated by RECIST) to evaluate immunological responses to evaluate quality of life


Enrollment: 10
Study Start Date: December 2009
Study Completion Date: November 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety
CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Biological: CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1
CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Detailed Description:
CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules and identified that these peptides significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of these peptides. Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1,URLC10,KIF20A,DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptides vaccine. Also we evaluate the immunological and clinical response of this vaccine therapy.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or recurrent breast cancer
  • Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
  • Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • HLA-A*2402
  • Laboratory values as follows

    • 2000/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

Exclusion Criteria:

  • 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
  • Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259505


Locations
Japan
Tokyo Medical University Ibaraki Medical Center
Ami Inashiki, Ibaraki, Japan, 300-0395
Sponsors and Collaborators
Tokyo Medical University
Tokyo University
Saint Luca International Hospital
  More Information

Responsible Party: Minoru Fujimori, Professor, Tokyo Medical University
ClinicalTrials.gov Identifier: NCT01259505     History of Changes
Other Study ID Numbers: MBCCTA-001-STT
First Submitted: December 11, 2010
First Posted: December 14, 2010
Last Update Posted: November 17, 2014
Last Verified: November 2014

Keywords provided by Minoru Fujimori, Tokyo Medical University:
no number

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases