Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer

NCT00678509 | Terminated Phase 1 DMC

• 1 other identifier: Breast-A24-I, II
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

HLA-A*2402; Peptide Vaccine; TTK

Outcome Measures

Primary Outcomes (1)

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

  2 months

Secondary Outcomes (1)

• to evaluate immunological responses

  2 months

Study Arms (1)

A

EXPERIMENTAL

Biological: TTK peptide mixed with Montanide ISA 51

Interventions

TTK peptide mixed with Montanide ISA 51 BIOLOGICAL

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

A

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• /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
• Decision of unsuitableness by principal investigator or physician-in-charge

Sponsors & Collaborators

• Tokyo University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

The Institute of Medical Science, the University of Tokyo

Minato-ku, Tokyo, 108-8639, Japan

Location

Related Links

• Research Hospital, the Institute of Medical Science, the University of Tokyo

MeSH Terms

Conditions

Breast Neoplasms

Interventions

montanide ISA 51

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Masaru Shinozaki, MD/PhD

  Head, Department of Surgery

  PRINCIPAL INVESTIGATOR

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 12, 2008
• First Posted: May 15, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-03

Locations

JP (1)