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Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer


Phase 1
20 Years
85 Years
Open (Enrolling)
Both
Metastatic Breast Cancer

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Trial Information

Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer


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.


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
- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 month

Safety Issue:

Yes

Authority:

Japan: Institutional Review Board

Study ID:

MBCCTA-001-STT

NCT ID:

NCT01259505

Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Metastatic Breast Cancer
  • no number
  • Breast Neoplasms

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