Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Tokyo Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tokyo University
Saint Luca International Hospital
Information provided by (Responsible Party):
Minoru Fujimori, Tokyo Medical University
ClinicalTrials.gov Identifier:
NCT01259505
First received: December 11, 2010
Last updated: June 27, 2012
Last verified: June 2012
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Tokyo Medical University:

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

Secondary Outcome Measures:
  • to evaluate efficacy (feasibility as evaluated by RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 9
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259505

Locations
Japan
Tokyo Medical University Ibaraki Medical Center Recruiting
Ami Inashiki, Ibaraki, Japan, 300-0395
Contact: Minoru Fujimori, M.D., Ph.D.    +81-29-887-1161      
Contact: MInoru Fujimori, M.D., Ph.D.    +81-29-887-1161      
Sponsors and Collaborators
Tokyo Medical University
Tokyo University
Saint Luca International Hospital
  More Information

No publications provided

Responsible Party: Minoru Fujimori, Professor, Tokyo Medical University
ClinicalTrials.gov Identifier: NCT01259505     History of Changes
Other Study ID Numbers: MBCCTA-001-STT
Study First Received: December 11, 2010
Last Updated: June 27, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo Medical University:
no number

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

ClinicalTrials.gov processed this record on October 21, 2014