melanoma
Conditions
Interventions
Inject an appropriate amount of MCL into cutaneous or subcutaneous metastatic lesions locally and put an alternative magnetic field on them to keep at the temparature of 43-46 degree for 30 min. Topi
Sponsors
Department of Dermatology, Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stage 3c or 4 melanoma patients 2. Patients who have at least one cutaneous or subcutaneous matastasis ( whole nodule must be located within 30 mm depth from skin surface in the case of subcutaneous metastasis) 3. Size and distribution of all the metastastatic lesions are recognized with clinical findings are known with clinical findings including imaging studies (CT, MRI or US) 4. Patients are ranged from 20 to 79 years old, regardless of sex. 5. Patients who failed to respond to standard therapies including surgery, chemotherapy and immunotherapy or are judged inappropriate to receive these treatment. 6. An anti-cancer therapy has not been given within previous 4 weeks 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) od 0-2 8. Patients without severe disorders -severe myelosuppression (WBC<2,000/ul, PLT<50,000/ul, Hb<8.5 g/dl) -liver dysfunction (AST, ALT>2 folds of upper normal limit, T. Bil>2.5 mg/dl) -chronic renal dysfunction (Cre>2.5 mg/dl) 9. Patients who have given informed consent
Exclusion criteria
Exclusion criteria: 1. An anti-ancer therapy has been recieved within previoous 4 weeks 2. Patients who have brain matastases 3. Patients who have a life expectancy of less than 6 months 4. Patients who are pregnant or nursing 5. Patients who have severe pleural or pericardial effusion or ascites 6. Patients who have active infection 7. Patients who have other malignancies 8. Patients who are unable to keep protocol due to psychiatric, familial, social or traffic disadvantage 9. Patients who have metals inside the body near (within 10 cm) the lesion where alternative magnetic field is put 10. Patients who have active asthma, or have had severe anaphilaxis before 11. Patients who are judged inappropriate to be enrolled in this study by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT AE Local antitumor effect | — |
Countries
Japan
Contacts
Public ContactKazuhiko Matsumoto, M.D., Ph.D.
Shinshu University Hospital Department of Dermatology
Outcome results
None listed