Clinical trial NCT01259505: Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer
Official title: Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: no number
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
Collaborators: name: Tokyo University
name: Saint Luca International Hospital
First posted: 2010-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: safety (Phase I: toxicities as assessed by NCI CTCAE version3)
timeFrame: 1 month
Secondary outcomes:
measure: to evaluate efficacy (feasibility as evaluated by RECIST)
timeFrame: 2 months
Other outcomes:
Locations:
city: Ami Inashiki
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
Study officials:
References: