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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002376
Receipt No. R000002889
Scientific Title Phase I/II clinical trial of inactivated HVJ-E administration for advanced malignant melanoma patients
Date of disclosure of the study information 2009/08/26
Last modified on 2009/08/25

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Basic information
Public title Phase I/II clinical trial of inactivated HVJ-E administration for advanced malignant melanoma patients
Acronym HVJ-E01/Melanoma/OUH-MTR
Scientific Title Phase I/II clinical trial of inactivated HVJ-E administration for advanced malignant melanoma patients
Scientific Title:Acronym HVJ-E01/Melanoma/OUH-MTR
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety, antitumor immunity, and clinical effect of inactivated HVJ-E for advanced melanoma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Assessing the safety and tolerability of inactivated HVJ-E
Key secondary outcomes Assessing the antitumor immunity and validity of inactivated HVJ-E

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
Interventions/Control_1 HVJ-E solution
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patient has provided a written informed consent prior to any study-related procedure.
2) The patient is at least over 20 years and equal to below 90 years old.
3) The patient has a diagnosis of malignant tumor as confirmed by histopathology or cytology.
4) The patient has a diagnosis of malignant melanoma progressive melanoma in AJCC stage IIIC or stage IV who meets either below condition;
#Recurrent
#Refractory or inapplicable to a standard treatment
#The patient refuses a standard treatment.
5) The patient has one or more administrationable lesion of HVJ-E solution on the skin, subcutis, or lymph node (less than 25 cm2 in size measured by forceps calipers, CT, or MRI review).
6) The patient has a life expectancy for at least 12 weeks or more.
7) The patient has a ECOG Performance Status Scale of 0 or 1.
8) The patient has measurable lesions (calipers, CT, or MRI review).
9) The organs function adequately evaluated by the following lab values;
WBC: equal or more than 2,000/mL
PLT: equal or more than 75,000/mL
Hemoglobin: equal or more than 8.0 g/dL
GOT: equal: or less than 100 IU/L
GPT: equal or less than 100 IU/L
T-Bil: equal or less than 2.5 mg/dL
Serum creatinine: equal or less than 2.3mg/dL
Key exclusion criteria 1) The patient has multiple brain metastases.
2) The patient shows positive immune response by HVJ-E prick test at screening.
3) The patient has a uncontrolled serious complication such as active infection.
4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks).
5) Participation in another clinical trial of another investigational medical product within 4 weeks.
6) History of a second independent malignancy within 2 years.
7) History of active autoimmune disease
8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisone over 6 months.
9) The patient is a pregnant or lactating female.
10) Clinically relevant psychiatric disorders/ legal incapacity or a limited legal capacity.
11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue.
12) Females with childbearing potential must have a positive b-HCG pregnancy test at screening.
13) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range.
14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Katayama
Organization Osaka University Graduate School of Medicine
Division name Dermatology
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6879-3031
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rie Sumida, Tatsuhiro Hanai
Organization Osaka University Hospital
Division name Medical Center for Translational Research
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Dermatology Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute for Advanced Medical Research Keio University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 26 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
Date of protocol fixation
2009 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 25 Day
Last modified on
2009 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002889

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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