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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006629
Receipt No. R000007832
Scientific Title Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma
Date of disclosure of the study information 2011/11/07
Last modified on 2017/03/14

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Basic information
Public title Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma
Acronym Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma (DC7)
Scientific Title Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma
Scientific Title:Acronym Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma (DC7)
Region
Japan

Condition
Condition unresectable malignant melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of the peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with unresectable advanced malignant melanoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events
Response rate
Progression free survival
Overall survival
Key secondary outcomes Immune induction (Delayed type hypersensitivity DTH for melanoma-antigen peptide)

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
Medicine Vaccine
Interventions/Control_1 Carboplatin AUC5/day day1, paclitaxel 175mg/m2/day day1, Dendritic cell day8, 22,
q4w, 3 cycle
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histopathologically proven unresectable malignant melanoma patients
2)Possess HLA-A02 or HLA-A24
3)Patients who don't have immediate allergy to melanoma peptide
4)Obtains lesion that can be evaluated by RECIST
5)At least 4 weeks after the prior treatment
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
7)Adequate hematologic, hepatic, renal, and cardiac function
a)WBC >=3,000/mm3
b)Absolute neutrophil count 1,500/mm3
c)Platelet >=100,000/mm3
d)Hemoglobin >=9.0g/dL
e)AST and ALT <=150IU/L
f)Total bilirubin <=3.0mg/dL
g)Creatinine <=1.5mg/dL
h)ECG normal
9)Patients who have a life expectancy of more than 4 months
10)Patients who have given informed consent
Key exclusion criteria 1)Patients who have active other primary malignancies
2)Patients who have past history of severe allergy
3)Patients who have severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes)
4)Patients who have pleural effusion or pericardial fluid requiring treatment
5)Patients who are pregnant or nursing
6)Male hope to impregnate
7)Carrier of HBV, HCV, HTLV-1, HIV and so on
8)Patients who have severe psychiatric disease
9)Patients who have past history of autoimmune disease
10)During treatment with immunosuppressive agents
11)During treatment with Disulfiram, Cyanamide, carmofur or Procarbazine Hydrochloride
12)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Amagai
Organization Keio University, School of Medicine
Division name Depertment of Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email amagai@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeru Funakoshi
Organization Keio University, School of Medicine
Division name Depertment of Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email takeruf@a8.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Tella Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Midtown Medical Center
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 慶應義塾大学病院(東京都)、東京ミッドタウンクリニック

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28263240
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
2011 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 21 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 29 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007832

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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