Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restric... | NCT00678509

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

NCT00678509

Sponsor

Tokyo University

Status

Terminated

Last Update Posted

Dec 29, 2009Estimated

Enrollment

14Estimated

Phase

Phase 1Phase 2

Conditions

Breast Cancer

Interventions

TTK peptide mixed with Montanide ISA 51

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of financial support

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 12, 2008

First Submission Date that Met QC Criteria

May 14, 2008

First Posted Date

May 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2009

Last Update Posted Date

Dec 29, 2009Estimated

Name	Class
Human Genome Center, Institute of Medical Science, University of Tokyo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

TTK has 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 peptide derived from this molecule and identified that this peptide significantly induces 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 that peptide. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, TTK-A24-567 peptide (1mg) 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 this peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Biological: TTK peptide mixed with Montanide ISA 51

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: feasibility as evaluated by RECIST)		2 months

Measure	Description	Time Frame
to evaluate immunological responses		2 months

Eligibility Module

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
Uncontrolled brain and/or intraspinal
Decision of unsuitableness by principal investigator or physician-in-charge

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases