UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010158 |
|---|---|
| Receipt number | R000011876 |
| 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 |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2019/03/12 12:43:57 |
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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
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
yasuwr@md.okayama-u.ac.jp
Public contact
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
htazawa@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011876
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