UMIN-CTR Clinical Trial

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

unresectable malignant melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Adverse events
Response rate
Progression free survival
Overall survival

Key secondary outcomes

Immune induction (Delayed type hypersensitivity DTH for melanoma-antigen peptide)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Keio University, School of Medicine

Institute

Department

Personal name

Organization

Tella Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Tokyo Midtown Medical Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2011

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 related 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