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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002701
Receipt No. R000003291
Scientific Title Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Date of disclosure of the study information 2009/11/04
Last modified on 2013/11/05

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Basic information
Public title Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Acronym Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Scientific Title Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Scientific Title:Acronym Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Region
Japan

Condition
Condition subcutaneous recurrent tumor (breast cancer, malignant head and neck tumor, malignant soft tissue tumor, malignant oral cavity tumor)
Classification by specialty
Breast surgery Oto-rhino-laryngology Orthopedics
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This clinical trial is phase I trial to establish immune-hyperthermia using cationic magnetoliposome and alternative magnetic field irradiation as a new modality for refractory subcutaneous tumor. The safety of this immune-hyperthermia will be evaluated for the patients with measurable subcutaneous recurrent tumor which is diagnosed histologically or cytologically. The effectiveness of this modality will be also evaluated.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicity and other adverse events
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 cationic magnetoliposome
level I: 5mg/body
level II: 50mg/body
level III: 200mg/body
Alternative magnetic field irradiation on the day of injection and the next day
Resection of injected tumor on the forteenth day of injection
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 The case with metastatic measurable tumor in skin or subcutaneous tissue (including lymph node) which is confirmed histologically or cytologically and also the tumor should be larger than the size of designated level.
Refractory to the standard medical therapy (chemotherapy, hormonal therapy, etc) and more than 4 weeks should elapse since the latest treatment.
The case who underwent radiotherapy more than 4 weeks earlier or without indication for radiotherapy
The case with the tumor which can be punctured. The tumor should be located less than 30mm in depth and also amenable to injection.
Performance status(ECOG) 0 to 2.
White blood cell counts >=2,000/uL or neutrophil counts >=1,000/uL
Platelets >=50,000/uL
Serum creatinine <=3mg/dl
AST(GOT)/ALT(GPT) both <=100 IU/L or <=5 X institutional criterion
Having written informed consent.
Key exclusion criteria The case having intracorporal magnetic substance (cardiac pace maker, dental implant, steel clips, steel bolts)
Pregnant woman, nursing woman
The case having pleural effusion, ascites, pericardial effusion which requires emergent treatment
The case having active infection
The case having double cancer with less than 5 year-disease free period
The case having psychological, familial, social, geographical factors which hamper compliance with the protocol and appropriate follow-up
The case having brain metastases which require emergent treatment for brain hypertension or emergent irradiation
The case who is considered to be inappropriate for this trial by the attending doctor
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyone Kikumori
Organization Nagoya University Hospital
Division name Department of Breast and Endocrine Surgery
Zip code
Address 65 Tsurumaicho, Showaku, Nagoya
TEL 052-744-2251
Email kikumori@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyone Kikumori
Organization Nagoya University Hospital
Division name Department of Breast and Endocrine Surgery
Zip code
Address 65 Tsurumaicho, Showaku, Nagoya
TEL 052-744-2251
Homepage URL
Email kikumori@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Hospital
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
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 11 Month 04 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 11 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 11 Month 02 Day
Last modified on
2013 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003291

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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