UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023120 |
|---|---|
| Receipt number | R000026464 |
| Scientific Title | Open-label, dose-escalating clinical trial of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) by local administration to evaluate the safety / tolerability and preliminary efficacy in patients with advanced solid tumors (Phase I trial). |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2019/11/09 18:59:01 |
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Basic information
Public title
Open-label, dose-escalating clinical trial of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) by local administration to evaluate the safety / tolerability and preliminary efficacy in patients with advanced solid tumors (Phase I trial).
Acronym
Phase I clinical trial of a local administration of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) in patients with advanced solid tumors.
Scientific Title
Open-label, dose-escalating clinical trial of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) by local administration to evaluate the safety / tolerability and preliminary efficacy in patients with advanced solid tumors (Phase I trial).
Scientific Title:Acronym
Phase I clinical trial of a local administration of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) in patients with advanced solid tumors.
Region
| Japan |
Condition
Condition
Advanced solid tumors for whom no standard therapy is available (primary malignant bone tumor, metastatic malignant bone tumor, primary malignant soft tissue tumor, metastatic malignant soft tissue tumor)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety / tolerability of a local administration of Surv.m-CRA-1 in patients with advanced solid tumors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse events and side effects
Key secondary outcomes
1) Detection of adenovirus in peripheral blood
2) Urinary excretion of Adenovirus
3) Adenoviral titer
4) Cytokines
5) Local response rate
6) Reduction rate in long diameter of the tumor
7) Pathological evaluation for tumor necrosis
8) Adenovirus infection in tumor
9) Performance status and visual analogue scale
10) Function of affected limb
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single, intratumoral administration of Surv.m-CRA-1
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
| 10 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically diagnosed as one of followings;
primary malignant bone tumor
metastatic malignant bone tumor
primary malignant soft tissue tumor
metastatic malignant soft tissue tumor
2) More than 4 weeks has passed since prior standard treatment
3) No standard therapy is available
4) With a measurable disease of short, long diameters and height and the lesion has enough volume to be injected with Surv.m-CRA-1.
5) Aged 10 years or older and younger than 85 years at the time of consent.
6) Performance status of 0~2.
7) Life expectancy of longer than 3 months
8) Adequate organ function as defined below:
Hb => 8 g/dL
WBC => 2,000 /microL
Plt => 70,000 /microL
AST(GOT) <= 100 U/L
ALT(GPT) <= 100 U/L
Total bil <= 1.5 mg/dL
Serum Cr <= 2.0 mg/dL
9) Use of effective contraception, if procreative potential exists.
10) Provide written informed consent
Key exclusion criteria
1) Patients with the following illness:
Severe heart disease, respiratory disease, digestive disease or liver disease.
Uncontrolled diabetes
Infectious disease that needs continuous treatment
2) A history of allergic reactions to penicillin, pork or beef (including milk)
3) Ongoing illness that requires immunosuppressant or corticosteroid administration
4) Currently active or past malignancies within the past five years
5) Uncontrollable fever or pain from the tumor
6) Pregnant, breast-feeding or woman with positive pregnancy test within 1 year after menopause.
7) Treated with non-approved drug within 4 weeks of study entry.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nagano |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Orthopaedic Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-5381
naga@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitaka Futagawa |
Organization
Kagoshima University Hospital
Division name
Division of Clinical Trial, Clinical Research Management Center
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-5553
Homepage URL
toshi27@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Gene Therapy and Regenerative Medicine, Graduate School of Medical and Dental Sciences, Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
鹿児島大学医学部・歯学部付属病院（鹿児島県）/
Kagoshima university hospital (Kagoshima)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026464
| 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 |
