UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006629 |
|---|---|
| Receipt number | 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 20:42:25 |
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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
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
takeruf@a8.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007832
