UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005087 |
|---|---|
| Receipt number | 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 17:13:49 |
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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/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
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
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
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006049
