UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	toshi27@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Department of Gene Therapy and Regenerative Medicine, Graduate School of Medical and Dental Sciences, Kagoshima university
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026464