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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005087
Receipt No. R000006049
Scientific Title Phase I/II study of a novel peptide vaccination therapy, CDCA1 and KOC1, for previously treated advanced non-small-cell lung cancer
Date of disclosure of the study information 2011/02/15
Last modified on 2013/02/15

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Basic information
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
Condition previously treated advanced non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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.

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 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

Eligibility
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/&micro;l or more, platelet count of 75,000/&micro;l 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

Research contact person
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

Public contact
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

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Medical Science, University of Tokyo
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 昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 15 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 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
Other related information

Management information
Registered date
2011 Year 02 Month 15 Day
Last modified on
2013 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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