A phase I study of SMP-105 (BCG-CWS) in patients with advanced cancers refractory to the standard treatment
Phase 1
- Conditions
- Malignant tumors
- Registration Number
- JPRN-UMIN000008485
- Lead Sponsor
- Kobe Haborland Immunotherapy Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Profile of adverse events, maximum tolerated dose (MTD), dose limiting toxicity (DLT), and recommended dose (RD).
- Secondary Outcome Measures
Name Time Method Quality of life (QOL), induction of interferon-gamma, and tuberculin skin test.