UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003725 |
|---|---|
| Receipt number | R000004507 |
| Scientific Title | Phase I study of Chemo-Immunotherapy in patients with relapsed and refractory head and neck carcinoma |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2016/01/28 11:22:01 |
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Basic information
Public title
Phase I study of Chemo-Immunotherapy in patients with relapsed and refractory head and neck carcinoma
Acronym
Phase I study of Chemo-Immunotherapy in head and neck cancer patients
Scientific Title
Phase I study of Chemo-Immunotherapy in patients with relapsed and refractory head and neck carcinoma
Scientific Title:Acronym
Phase I study of Chemo-Immunotherapy in head and neck cancer patients
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the safety and feasibility
To assessment of immune responses
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To assess the safety by evaluating local and systemic adverse reactions
Key secondary outcomes
To evaluate the immune responses of treated patients
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 | Vaccine |
Interventions/Control_1
Cyclophosphamide/Docetaxel/autologous dendritic cells/OK-432
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
1. The patients with relapsed head and neck squamous cell carcinoma
2. The patients with refractory head and neck squamous cell carcinoma
3. 20 years and older
4. ECOG performance status 0-1
5. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
6. Tumor lesions are accessible to intratumoral dendritic cells injection
7. Patients who are able to do oral ingestion
8. Patients must have normal organ and marrow functions as follows:
i) Hb>9.0 mg/dl
ii)Ht>25%
iii)WBC>4000/mm3
iv)Platelet count>100,000/mm3
v)T-Bil<1.5mg/dl
vi)GOT<x2.5 institutional upper limit of normal
vii)GPT<x2.5 institutional upper limit of normal
viii)Creatinin<1.5mg/dl
9. signed informed consent
Key exclusion criteria
1. Less than 20 years
2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
3. Patients with clinically active infection
4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
5. Concomitant malignant diseases, brain metastases
6. Psychiatric illness
7. Treatment with steroids
8. Decision of unsuitableness by physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Masuyama |
Organization
University of Yamanashi Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
Shimokato 1110, Chuo, Yamanashi
TEL
055-273-6769
mkeisuke@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Ishii |
Organization
University of Yamanashi Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
Shimokato 1110, Chuo, Yamanashi
TEL
055-273-6769
Homepage URL
ishiih@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01149902
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山梨大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | 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
| 2010 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 08 | Day |
Last modified on
| 2016 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004507
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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