UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003191 |
|---|---|
| Receipt number | R000003652 |
| Scientific Title | Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Small Cell Lung Cancer Refractory to Standard Therapy (Phase I study). |
| Date of disclosure of the study information | 2010/02/16 |
| Last modified on | 2019/03/31 22:40:48 |
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Basic information
Public title
Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Small Cell Lung Cancer Refractory to Standard Therapy (Phase I study).
Acronym
Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Refractory Small Cell Lung Cancer
Scientific Title
Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Small Cell Lung Cancer Refractory to Standard Therapy (Phase I study).
Scientific Title:Acronym
Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Refractory Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety, tolerability, adverse effects, immune response and clinical efficacy of different doses of HLA-A*2402 restricted epitope peptides (CDCA1 and KIF20A) in treating patients with small cell lung cancer refractory to standard therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of safety and tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) as well as adverse effects of vaccination therapy, and determination of the recommended dose for next phase trial.
Key secondary outcomes
1.Evaluation of immunological responses
Peptides specific CTL responses in vitro
Antigen cascade
Changes in levels of regulatory T cells
Expression of cancer antigens and HLA
2.Evaluation of clinical efficacy
Objective response rate (by RECIST)
Monitoring of tumor markers
Overall survival
Progression free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Interventions/Control_2
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (2mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Interventions/Control_3
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*2402-restricted CDCA1 peptide (3mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
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. SCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
6. Life expectancy > 3 months
7. Laboratory values as follows
1500/mm3 < WBC < 15000/mm3
Platelet count > 75000/mm3
Asparate transaminase < 3 X cutoff value
Alanine transaminase < 3 X cutoff value
Total bilirubin < 3 X cutoff value
Serum creatinine < 2X cutoff value
8. HLA-A*2402
9. Able and willing to give valid written informed consent
Key exclusion criteria
1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or
immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yataro Daigo MD, PhD |
Organization
Shiga University of Medical Science
Division name
Department of Medical Oncology
Zip code
Address
Tsukinowa-cho, Otsu, Shiga 520-2192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiga University of Medical Science
Division name
Department of Medical Oncology
Zip code
Address
Tsukinowa-cho, Otsu, Shiga 520-2192, Japan
TEL
Homepage URL
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Genome Center, Institute of Medical Science, The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01069653
Org. issuing International ID_1
U.S. National Institutes of Health (ClinicalTrials.gov)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 16 | 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 | 29 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003652
