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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008485
Receipt No. R000009976
Scientific Title A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Date of disclosure of the study information 2012/07/25
Last modified on 2013/01/24

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Basic information
Public title A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Acronym A phase I study of SMP-105 (BCG-CWS)
Scientific Title A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Scientific Title:Acronym A phase I 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 estimate the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose (RD) of SMP-105 in patients with advanced cancer refractory to the standard treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety: Profile of adverse events, maximum tolerated dose (MTD), dose limiting toxicity (DLT), and recommended dose (RD).
Key secondary outcomes Quality of life (QOL), induction of interferon-gamma, and tuberculin skin test.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intradermal injection of 50 microgram SMP-105, weekly, four cycles
Interventions/Control_2 Intradermal injection of 100 microgram SMP-105, weekly, four cycles
Interventions/Control_3 Intradermal injection of 200 microgram SMP-105, weekly, four cycles
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
75 years-old >=
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 20 to 75 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 syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis, and so on).
3) Patients who need the treatment with corticosteroids and immunesuppressive 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 9

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

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

Sponsor
Institute Kobe Haborland Immunotherapy Clinic
Institute
Department

Funding Source
Organization 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)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 25 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 06 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2013 Year 01 Month 21 Day
Date of closure to data entry
2013 Year 01 Month 21 Day
Date trial data considered complete
2013 Year 01 Month 21 Day
Date analysis concluded
2013 Year 01 Month 21 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 20 Day
Last modified on
2013 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009976

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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