UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Title of the study (Brief title)	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	Kiyoshi Yokokawa
Organization	Kobe Haborland Immunotherapy Clinic
Division name	Clinic director
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	Kiyoshi Yokokawa
Organization	Kobe Haborland Immunotherapy Clinic
Division name	Clinic director
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011628