melanoma
Conditions
Interventions
Inject an appropriate amount of MML into cutaneous or subcutaneous matastatic lesions locally, and put an alternative magnetic field on them to keep at the temperature of 43-46 degree for 30 min.
Sponsors
Department of Dermatology, Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stage IIIc or IV melanoma patients 2. Patients who have at least one cutaneous or subcutaneous metastasis (the whole nodule is located within 30 mm depth from skin surface in the case of subcutaneous metastases) 3. Expression of HMW-MAA (High Molecular Weight - Melanoma Associate Antigen) is confirmed immunohistochemically on melanoma cells in a primary lesion or at least one metastatic lesion. 4. The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI or US). 5. Patients are ranged from 20 to 80 years old, regardless of sex. 6. Patients who failed to respond to standard therapies including surgery, chemotherapy and immunotherapy or are judged inappropriate to receive these treatments. 7. An anti-cancer therapy has not been given within previous 4 weeks. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 9. Patients without severe disorders -severe myelosuppresion (WBC<2000/ul,PLT<50,000/ul, Hb<8.5 g/dl) -bleeding tendency -liver dysfunction (AST, ALT> 2 folds of upper normal limit, T.Bil>2.5 mg/dl) -chronic renal dysfunction (Cre>2.5 mg/dl) 10. Patients who have given informed consent
Exclusion criteria
Exclusion criteria: 1. An anti-cancer therapy has been received within previous 4 weeks 2. Patients who have brain metastases 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 anaphylaxis before. 11. Patients who are judged inappropriate to be enrolled in this study by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT (Dose Limiting Toxicity) AE (Adverse Event) Local antitumor effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic antitumor effects 1. antitumor effect on non-heated lesions 2. level of tumor markers in the patients' sera 3. PFS (Progression Free Survival) 4. OS (Overall Survival) | — |
Countries
Japan
Contacts
Public ContactKazuhiko Matsumoto, M.D., Ph.D.
Shinshu University Hospital Department of Dermatology
Outcome results
None listed