UMIN-CTR Clinical Trial

Public title

Phase I/II study of a novel peptide vaccination therapy, CDCA1 and KOC1, for previously treated advanced non-small-cell lung cancer

Acronym

Novel peptide vaccination therapy for previously treated advanced NSCLC

Scientific Title

Phase I/II study of a novel peptide vaccination therapy, CDCA1 and KOC1, for previously treated advanced non-small-cell lung cancer

Scientific Title:Acronym

Novel peptide vaccination therapy for previously treated advanced NSCLC

Region

Japan

Condition

previously treated advanced non-small-cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the safety and efficacy of a novel peptide vaccination therapy, CDCA1 and KOC1, in patients with previously treated advanced non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

To assess the safety, maximum tolerated dose, and recommended dose in phase I.
To assess the progression-free survival in phase II.

Key secondary outcomes

To assess the response rates, QOL, and the immunological responses in phase I. To assess the response rates, the safety, overall survival, QOL, and the immunological responses in phase II.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Vacctination therapy of CDCA1 and KOC1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with NSCLC who had previously received cytotoxic chemotherapy and who had been resistant to standard therapy were enrolled. The criteria for study entry were as follows: 1) histologically or cytologically confirmed NSCLC; 2) stage III or IV disease; 3) age 20 years or older; 4) Eastern Cooperative Oncology Group PS of 3 or less; 5) measurable or assessable lesions; 6) HLA-A*2402 positive; 7) life expectancy of at least 2 months; 8) adequate bone marrow function (neutrophil count of 1500/µl or more, platelet count of 75,000/µl or more, and hemoglobin level of 8 g/dl or more), hepatic function (total serum bilirubin level less than 2 mg/dl, levels of aspartate aminotransferase and alanine aminotransferase less than or equal to three times the upper limits of the normal ranges), and renal function (serum creatinine level less than 2 mg/dl).

Key exclusion criteria

Patients were excluded if they have already received vaccination therapy, they had severe heart disease, active infection, severe drug allergy, other serious underlying medical conditions, symptomatic brain metastasis, or an active second malignancy, and they received steroids or immunosuppressing agent.

Target sample size

26

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Hirose

Organization

Showa University School of Medicine

Division name

Division of Respiratory Medicine and Allergology, Department of Internal Medicine

Zip code

Address

1-5-8 Hatanodai, Shinagawa, Tokyo

TEL

+81-3-3784-8532

Email

Name of contact person

1st name
Middle name
Last name	Takashi Hirose

Organization

Showa University School of Medicine

Division name

Division of Respiratory Medicine and Allergology, Department of Internal Medicine

Zip code

Address

1-5-8 Hatanodai, Shinagawa, Tokyo

TEL

+81-3-3784-8532

Homepage URL

Email

Institute

Showa University School of Medicine

Institute

Department

Personal name

Organization

Showa University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Institute of Medical Science, University of Tokyo

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

昭和大学病院（東京都）

Date of disclosure of the study information

2011

Year

02

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

10

Month

22

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

15

Day

Last modified on

2013

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006049