Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
20 Years
85 Years
Both
Breast Cancer
Trial Information
Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that
peptides derived from these receptors 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 those peptides. Patients will be vaccinated
twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide
(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated
cycles of the 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 peptide vaccine. In the following phase II study, we evaluate the
immunological and clinical response of this vaccine therapy.
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*0201
- Laboratory values as follows
- 2000/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
- Unhealed external wound
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- Uncontrolled brain and/or intraspinal lesion(s)
- Decision of unsuitableness by principal investigator or physician-in-charge
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Outcome Time Frame:
2 months
Safety Issue:
Yes
Principal Investigator
Naohide Yamashita, MD/PhD
Investigator Role:
Study Chair
Investigator Affiliation:
The Institute of Medical Science, The University of Tokyo
Authority:
Japan: Institutional Review Board
Study ID:
Breast-A02-I, II
NCT ID:
NCT00677326
Start Date:
May 2008
Completion Date:
May 2009
Related Keywords:
- Breast Cancer
- HLA-A*0201
- Peptide Vaccine
- VEGFR1
- VEGFR2
- Breast Neoplasms
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