UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of peptide pulsed dendritic cell vaccination combined with carboplatin and paclitaxel for patients with advanced malignant melanoma
Title of the study (Brief title)	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	Masayuki Amagai
Organization	Keio University, School of Medicine
Division name	Depertment of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	amagai@a7.keio.jp

Public contact
Name of contact person	Takeru Funakoshi
Organization	Keio University, School of Medicine
Division name	Depertment of Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28263240
Results
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