UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004617 |
|---|---|
| Receipt number | R000005488 |
| Scientific Title | Combined modality treatment for patients with stage IV melanoma: Cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2014/05/24 11:43:14 |
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Basic information
Public title
Combined modality treatment for patients with stage IV melanoma: Cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells
Acronym
Combination of cyclophosphamide and a dendritic cell vaccine for stage IV melanoma
Scientific Title
Combined modality treatment for patients with stage IV melanoma: Cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells
Scientific Title:Acronym
Combination of cyclophosphamide and a dendritic cell vaccine for stage IV melanoma
Region
| Japan |
Condition
Condition
melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety, efficacy, and feasibility of combination of cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells for stage IV melanoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Toxicity of NCI-CTC grade 3 or 4, response rate
Key secondary outcomes
Pass rate of release tests for dendritic cell vaccine, completion rate of dendritic cell vaccine
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
| Vaccine |
Interventions/Control_1
Administer monocyte-derived dendritic cells subcutaneously every 2 weeks for 4 doses and then every 4 weeks for 3 doses. Administer low dose cyclophosphamide before administering dendritic cells.
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
| 21 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Biopsy-proven metastatic melanoma
2. PS (ECOG) 0 or 1
3. No active CNS metastatic disease
4. Patients have not received chemotherapy, IFN-alpha, high dose IL-2, corticosteroid or other immunosuppressive agents
5. adequate bone marrow, hepatic, and renal functions
6. Informed consent has been obtained
Key exclusion criteria
1. Patients with a history of neoplasitic disease other than melanoma within 5 years
2. Patients with a history of autoimmune disease
3. Patients with unstable angina pectoris, congestive heart failure, asthma or active systemic infection
4. Positive for HBs Ag, HCV Ab, HTLV-I Ab, HIV Ab, or serological test for syphilis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Miyachi |
Organization
Kyoto University Hospital
Division name
Department of Dermatology
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3310
ymiyachi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norimitsu Kadowaki |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3155
Homepage URL
kadowaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
SBI Biotech Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | 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
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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 24 | Day |
Last modified on
| 2014 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005488
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
