Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

NCT01259505 | Completed Phase 1 DMC

• 1 other identifier: MBCCTA-001-STT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

no number

Outcome Measures

Primary Outcomes (1)

• safety (Phase I: toxicities as assessed by NCI CTCAE version3)

  1 month

Secondary Outcomes (1)

• to evaluate efficacy (feasibility as evaluated by RECIST)

  2 months

Study Arms (1)

Safety

EXPERIMENTAL

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

Interventions

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 BIOLOGICAL

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.

Safety

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

Sponsors & Collaborators

• Tokyo Medical University: lead
• Tokyo University: collaborator
• Saint Luca International Hospital: collaborator

Study Sites (1)

Tokyo Medical University Ibaraki Medical Center

Ami Inashiki, Ibaraki, 300-0395, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

KIF20B protein, human

Condition Hierarchy (Ancestors)

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

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: Professor

Study Record Dates

• First Submitted: December 11, 2010
• First Posted: December 14, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2014
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

JP (1)