UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002408
Receipt number R000002952
Scientific Title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Date of disclosure of the study information 2009/09/01
Last modified on 2009/08/31 14:56:06

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Basic information

Public title

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Acronym

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Scientific Title

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Scientific Title:Acronym

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate safety and adverse effect on cancer vaccination therapy using three tumor-associated antigen peptides in patient with refractory breast cancer to chemotherapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Evaluation of safety and adverse effect of vaccination therapy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Three peputides restricted to HLA-A*2402(1.0mg for each)are administered 12 times once a week.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Advanced breast cancer which is refractory to any chemotherapy.
2.Age between 20 to 85
3.ECOG performance status 0-2
4.WBC > 3000/mm3
Platelet > 75000/mm3
Hemoglobon > 9.0g/dL
Serum creatinine <2.0mg/dL
Asparate transaminase > 120 IU/L
Alanine transaminase > 120 IU/L
Total bilirubin < 2.5mg/dL
5.More than 4 weeks later after treatment(chemotherapy/radiotherapy etc)
6.Life expectancy > 3 manths
7.HLA-A*2402
8.Have a lesion which can be measured by CT/MRI
9.Able and willing to give valid written informed cansent

Key exclusion criteria

1.No uncontrollable infections
2.No curative traumatic wound
3.No uncontrollable ulcera
4.No abnormal coagulation
5.Concurrent treatment with acetylsalicylic acid and/or NSAIDs
6.No thrombosis
7.No severe complications (heart failure etc)
8.No other malignancy requiring treatment
9.Concurrent treatment with steroids or immunosuppressing agent
10.No Psychosis
11.Pregnancy/Breast feeding
12.Decision of unsuitableness by principal investigator or physician in change

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsue Saito

Organization

Juntendo University School of Medicine

Division name

Department of Breast and Endocrine Surgery

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University School of Medicine

Division name

Department of Breast and Endocrine Surgery

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Breast and Endocrine Surgery, Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2009 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 08 Month 31 Day

Last modified on

2009 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002952


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name