UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000822 |
|---|---|
| Receipt number | R000000982 |
| Scientific Title | A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients |
| Date of disclosure of the study information | 2007/09/07 |
| Last modified on | 2011/03/08 16:07:21 |
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Basic information
Public title
A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients
Acronym
A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients
Scientific Title
A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients
Scientific Title:Acronym
A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients
Region
| Japan |
Condition
Condition
melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the heatimmunotherapy using anti-melanoma antibody conjugated magnetoliposome (MML) and an alternative magnetic field as a new treatment for advanced melanoma patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
DLT (Dose Limiting Toxicity)
AE (Adverse Event)
Local antitumor effects
Key secondary outcomes
Systemic antitumor effects
1. antitumor effect on non-heated lesions
2. level of tumor markers in the patients' sera
3. PFS (Progression Free Survival)
4. OS (Overall Survival)
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 MML into cutaneous or subcutaneous matastatic lesions locally, and put an alternative magnetic field on them to keep at the temperature of 43-46 degree for 30 min.
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 IIIc or IV melanoma patients
2. Patients who have at least one cutaneous or subcutaneous metastasis (the whole nodule is located within 30 mm depth from skin surface in the case of subcutaneous metastases)
3. Expression of HMW-MAA (High Molecular Weight - Melanoma Associate Antigen) is confirmed immunohistochemically on melanoma cells in a primary lesion or at least one metastatic lesion.
4. The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI or US).
5. Patients are ranged from 20 to 80 years old, regardless of sex.
6. Patients who failed to respond to standard therapies including surgery, chemotherapy and immunotherapy or are judged inappropriate to receive these treatments.
7. An anti-cancer therapy has not been given within previous 4 weeks.
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
9. Patients without severe disorders
-severe myelosuppresion (WBC<2000/ul,PLT<50,000/ul, Hb<8.5 g/dl)
-bleeding tendency
-liver dysfunction (AST, ALT> 2 folds of upper normal limit, T.Bil>2.5 mg/dl)
-chronic renal dysfunction (Cre>2.5 mg/dl)
10. Patients who have given informed consent
Key exclusion criteria
1. An anti-cancer therapy has been received within previous 4 weeks
2. Patients who have brain metastases
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 anaphylaxis before.
11. Patients who are judged inappropriate to be enrolled in this study by the doctor in charge
Target sample size
6
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
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
Homepage URL
Sponsor or person
Institute
Department of Dermatology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Cancer Translational Research Project
Organization
Division
Category of Funding Organization
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
| 2007 | Year | 09 | Month | 07 | 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
Completed
Date of protocol fixation
| 2007 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 06 | Day |
Last modified on
| 2011 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000982
