Unique ID issued by UMIN | UMIN000009922 |
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Receipt number | 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 14:27:24 |
A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
A phase II study of SMP-105 (BCG-CWS)
A phase II study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
A phase II study of SMP-105 (BCG-CWS)
Japan |
Malignant tumors
Medicine in general |
Malignancy
NO
To evaluate the efficacy and safety of SMP-105 (BCG-CWS) in patients with advanced cancer refractory to the standard treatment.
Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival rate at 6 months after initiation of therapy (Disease control rate)
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Kiyoshi Yokokawa |
Kobe Haborland Immunotherapy Clinic
Clinic director
Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044, Japan
078-360-3313
k.yokokawa@khic.jp
1st name | |
Middle name | |
Last name | Kiyoshi Yokokawa |
Kobe Haborland Immunotherapy Clinic
Clinic director
Kobe Harborland Center Building 14F, 1-3-3, Higashi Kawasakimachi, Chuo-ku, Kobe, Hyogo, 650-0044,
078-360-3313
k.yokokawa@khic.jp
Kobe Haborland Immunotherapy Clinic
The Study Group for Immunotherapy
NPO The Supporting Center for Clinical Research and Education
Other
NO
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)
2013 | Year | 02 | Month | 01 | Day |
Unpublished
No longer recruiting
2013 | Year | 01 | Month | 22 | Day |
2013 | Year | 02 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 04 | Month | 30 | Day |
2017 | Year | 05 | Month | 15 | Day |
2017 | Year | 05 | Month | 31 | Day |
2013 | Year | 01 | Month | 31 | Day |
2017 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011628
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