Malignant tumors
Conditions
Interventions
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.
Sponsors
Kobe Haborland Immunotherapy Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 6 months after initiation of therapy (Disease control rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactKiyoshi Yokokawa
Kobe Haborland Immunotherapy Clinic Clinic director
Outcome results
None listed