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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009922
Receipt No. R000011628
Scientific Title A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Date of disclosure of the study information 2013/02/01
Last modified on 2017/08/10

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Basic information
Public title A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Acronym A phase II study of SMP-105 (BCG-CWS)
Scientific Title A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Scientific Title:Acronym A phase II study of SMP-105 (BCG-CWS)
Region
Japan

Condition
Condition Malignant tumors
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of SMP-105 (BCG-CWS) in patients with advanced cancer refractory to the standard treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival rate at 6 months after initiation of therapy (Disease control rate)
Key secondary outcomes Progression-free survival, overall survival, tumor shrinkage effect of measurable lesions, change of tumor marker level, induction of interferon-gamma, tuberculin skin test, quality of life (QOL), and safety (type, frequency and degree of adverse events).

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 Patients receive intradermal injections of 100 microgram/body of SMP-105 four times weekly into the upper arm as the sensitization phase, and then every four weeks as the therapeutic phase.
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) Patients with histologically confirmed malignant tumors.
2) Patients with malignant tumors refractory to standard therapy or without any hope of its efficacy.
3) Patients without any prior therapies(surgery, radiotherapy, chemotherapy, hyperthermia, other immunotherapy, and so on) for at least two weeks and without their influence.
4) Patients aged over 20 years old.
5) Patients with at least three-month estimated life expectancy.
6) Patients with ECOG performance status of 0 to 2.
7) Adequate major organ functions and meeting the criteria below:
White blood cell counts >= 3,000/mm3
Absolute neutrophil counts >= 1500/mm3
Platelet counts >= 100,000/mm3
Hemoglobin >= 8.0 g/dL
AST and ALT <= 2 times the upper limit of normal
Serum bilirubin <= 1.5 times the upper limit of normal
Serum creatinine <= 1.5 times the upper limit of normal
No serious abnormal ECG
8) All patients are required to provide written informed consent.
Key exclusion criteria 1) Patients with severe complications(infectious disease, interstitial pneumonitis, cardiac disease, renal disease, hepatic disease, and uncontrolled diabetes mellitus).
2) Patients with autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis, and so on).
3) Patients who need the treatment with corticosteroids and immune-suppressive agents during this study (The use of their local and inhaled administration and non-steroidal anti-inflammatory agents is permitted).
4) Pregnant, lactating, or potentially to be pregnant.
5) Patients judged inappropriate for this study by responsible investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Yokokawa
Organization Kobe Haborland Immunotherapy Clinic
Division name Clinic director
Zip code
Address Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044, Japan
TEL 078-360-3313
Email k.yokokawa@khic.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Yokokawa
Organization Kobe Haborland Immunotherapy Clinic
Division name Clinic director
Zip code
Address Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044,
TEL 078-360-3313
Homepage URL
Email k.yokokawa@khic.jp

Sponsor
Institute Kobe Haborland Immunotherapy Clinic
Institute
Department

Funding Source
Organization The Study Group for Immunotherapy
NPO The Supporting Center for Clinical Research and Education
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 神戸ハーバーランド免疫療法クリニック (兵庫県)
堂島リーガクリニック(大阪府)
かなざわリーガクリニック(石川県)
医療法人 メイクリニック(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 No longer recruiting
Date of protocol fixation
2013 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 15 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 31 Day
Last modified on
2017 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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