UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of a tumor-selective oncolytic adenovirus (Telomelysin) in combination with ionizing radiation for head and neck and thoracic malignant tumors
Acronym	A clinical study of combination therapy with Telomelysin and radiation for malignant tumors
Scientific Title	A clinical study of a tumor-selective oncolytic adenovirus (Telomelysin) in combination with ionizing radiation for head and neck and thoracic malignant tumors
Scientific Title:Acronym	A clinical study of combination therapy with Telomelysin and radiation for malignant tumors
Region	Japan

Condition
Condition	Head and neck cancers, esophageal cancers, non-small cell lung cancers
Classification by specialty	Gastroenterology Pneumology Gastrointestinal surgery Chest surgery Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This is a Phase I/II, open-label, dose-escalation trial in patients with advanced head and neck and thoracic malignant tumors and scheduled to combine with ionizing radiation. Primary objective: To assess the safety (maximum tolerated dose) of Telomelysin intratumorally injected in combination with local ionizing radiation. Secondary objective: To assess the efficacy of Telomelysin in combination with local ionizing radiation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety -Spectrum and frequency of adverse events
Key secondary outcomes	Efficacy -Change in tumor size -Progression free survival -Overall survival

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
Interventions/Control_1	Three cohorts (1.0 x 10E10 vp, 1.0 x 10E11 vp, 1.0 x 10E12 vp) of 3 subjects each are planned in a dose-escalation phase, and 3 additional subjects will be treated at the highest safe dose. Telomelysin will be intratumorally administered at day 1, 18 and 32. Each patient will be treated with ionizing radiation (2 Gy/day, 5 days/week) for 5 weeks and additional 1 week.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	-Histologically or cytologically confirmed head and neck cancers, esophageal cancers and non-small cell lung cancers. -Locally invasive, surgically incurable advanced cancers. -Postoperative recurrent and surgically unresectable cancers. -Locally virus-injectable tumors. -Measurable and evaluable tumors. -Tumor area is more than 1 square centimeter and less than 25 square centimeters. -Patient who is expected to be alive for more than 12 weeks and Performance Status is 2 or less. -Patient who can give informed consent. -Patient who is not pregnant or nursing, or is using effective barrier birth control. -Patient who has intact function in bone marrow, liver and kidney.
Key exclusion criteria	-Patient who has uncontrolled infectious disease and/or severe disease. -Patient who received chemotherapy, laser irradiation or stent placement within 3 weeks (or used nitrosourea or mitomycin C within 6 weeks). -Patient who receives non-local adrenocortical steroid therapy. -Patient who participated in clinical study of other unapproved drug within 4 weeks. -Patient who has or had (has less than 2 years after diagnosis of) other malignant tumors except for head and neck and thoracic malignant tumors. -Patient who cannot be kept or followed in this study due to mental, familial, social, geographical reasons. -Patient who has past history of autogenous or allogenic organ and tissue transplantations. -Patient who has positive result in serological test for HIV1, HIV2, HBV and HCV. -Patient who are considered inadequate by investigator.
Target sample size	12

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yasuhiro Shirakawa
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city, Okayama, Japan
TEL	086-235-7257
Email	yasuwr@md.okayama-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Tazawa
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city, Okayama, Japan
TEL	086-235-7257
Homepage URL
Email	htazawa@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization
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	岡山大学病院（岡山） Okayama University Hospital (OKAYAMA)

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 18 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	2012 Year 08 Month 23 Day
Date of IRB	2010 Year 07 Month 12 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2018 Year 08 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 04 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011876