UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002376 |
|---|---|
| Receipt number | 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 03:42:44 |
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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
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
Sponsor or person
Institute
Department of Dermatology Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002889
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