UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008940
Receipt number R000010475
Scientific Title Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .
Date of disclosure of the study information 2012/09/19
Last modified on 2014/07/14 17:06:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .

Acronym

Phase II study of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients.

Scientific Title

Phase II randomised clinical trial of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies .

Scientific Title:Acronym

Phase II study of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients.

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with Ninjin-yoei-to for lung cancer patients resistant to standard therapies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Comparison of immune-enhancing effects between two groups.

Key secondary outcomes

1. Comparison of safety between two groups. 2. Comparison of overall survival between two groups .


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Vaccine

Interventions/Control_1

arm1:
The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).
Ninjin-yoei-to (3 g/time, 3 times/day) will be orally administered from the date of the first vaccination to the date of the sixth vaccination.

The peptide vaccination will be allowed to continue till four periods (24 times ) at the interval in every 2~4 weeks.

Interventions/Control_2

arm2:
The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).

The peptide vaccination will be allowed to continue till four periods (24 times ) at the interval in every 2~4 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects must satisfy the following conditions.
1) Patients must be diagnosed as lung cancer resistant to standard therapies. (Patients with inoperable cancer fail the chemotherapy of three or more regimens . Patients with cancer of recurrence after resection or radiotherapy.)
2) Patients must be at a score level 0-1 of ECOG performance status.

3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types.
4)Patients must be expected to survive more than 3 months.
5) Patient's laboratory data must satisfy the followings:
WBC is more than 2,500/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dl
Platelet is more than 80,000/mm3
Serum Creatinine is less than 2 times the ULN
Total bilirubin are less than 2 times the ULN
6) Patients must be more 20 and less than 75 year-old
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Key exclusion criteria

The following patients must be excluded:
1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al).
2)Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3)Patients with the past history of severe allergic reactions.
4)patients with pulmonary disorder (idiopathic pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonia,drug-induced pneumonia).
5)(Females) Pregnant or nursing patients. Patients desiring future fertility.
(Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
6)Patients who are judged inappropriate for entry to this clinical trial by doctors.
7)Patients who has taken Ninjin-yoei-to.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyogo Itoh

Organization

Kurume University

Division name

Cancer Vaccine Center

Zip code


Address

Kokubu-machi 155-1, Kurume, Fukuoka 839-0863

TEL

0942-27-5210

Email

kyogo@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Yamada

Organization

Kurume University

Division name

Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

Zip code


Address

67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan

TEL

0942-31-7744

Homepage URL


Email

akiymd@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University Cancer Vaccine Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2012 Year 09 Month 19 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

Terminated

Date of protocol fixation

2012 Year 08 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 09 Month 19 Day

Last modified on

2014 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010475


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name