UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006414 |
|---|---|
| Receipt number | R000007481 |
| Scientific Title | A pilot study of heat immunotherapy using cationic magnetoliposome for advanced melanoma patients - combined therapy with topical imiquimod immunotherapy |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2016/03/29 16:44:08 |
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Basic information
Public title
A pilot study of heat immunotherapy using cationic magnetoliposome for advanced melanoma patients -
combined therapy with topical imiquimod immunotherapy
Acronym
Combination of heat immunotherapy and topical imiquimod immunotherapy for adavanced melanoma
patients
Scientific Title
A pilot study of heat immunotherapy using cationic magnetoliposome for advanced melanoma patients -
combined therapy with topical imiquimod immunotherapy
Scientific Title:Acronym
Combination of heat immunotherapy and topical imiquimod immunotherapy for adavanced melanoma
patients
Region
| Japan |
Condition
Condition
melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the combination therapy of hyperthermia using cationic magnetoliposome and topical imiquimod immunotherapy as a new treatment for advanced melanoma patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLT
AE
Local antitumor effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inject an appropriate amount of MCL into
cutaneous or subcutaneous metastatic lesions locally and put an alternative magnetic field on them to keep at the temparature of 43-46 degree for 30 min. Topical 5% imiquimod cream is applied at 10 mm outside of the heated lesions
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Stage 3c or 4 melanoma patients
2. Patients who have at least one cutaneous or subcutaneous matastasis (
whole nodule must be located within 30 mm depth from skin surface in the case of subcutaneous metastasis)
3. Size and distribution of all the metastastatic lesions are recognized with clinical findings are known with clinical findings including imaging studies (CT, MRI or US)
4. Patients are ranged from 20 to
79 years old, regardless of sex.
5. Patients who failed to respond to standard therapies including surgery, chemotherapy and immunotherapy or are judged inappropriate to receive these treatment.
6. An anti-cancer therapy has not been given within previous 4 weeks
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) od 0-2
8. Patients without severe disorders
-severe myelosuppression
(WBC<2,000/ul, PLT<50,000/ul, Hb<8.5 g/dl)
-liver dysfunction
(AST, ALT>2 folds of upper normal limit, T. Bil>2.5 mg/dl)
-chronic renal dysfunction (Cre>2.5 mg/dl)
9. Patients who have given informed consent
Key exclusion criteria
1. An anti-ancer therapy has been recieved within previoous 4 weeks
2. Patients who have brain matastases
3. Patients who have a life expectancy of less than 6 months
4. Patients who are pregnant or nursing
5. Patients who have severe pleural or pericardial effusion or ascites
6. Patients who have active infection
7. Patients who have other malignancies
8. Patients who are unable to keep protocol due to psychiatric, familial, social or traffic disadvantage
9. Patients who have metals inside the body near (within 10 cm) the lesion where alternative magnetic field is put
10. Patients who have active asthma, or have had severe anaphilaxis before
11. Patients who are judged inappropriate to be enrolled in this study by clinical investigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Matsumoto, M.D., Ph.D |
Organization
Shinshu University Hospital
Division name
Department of Dermatology
Zip code
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-3389
climatsu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Matsumoto, M.D., Ph.D. |
Organization
Shinshu University Hospital
Division name
Department of Dermatology
Zip code
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-3389
Homepage URL
climatsu@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2011 | Year | 10 | Month | 01 | 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
The trial was terminated.
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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2016 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007481
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