advanced malignant melanoma
Conditions
Interventions
Sponsors
Department of Dermatology Osaka University Graduate School of Medicine
Institute for Advanced Medical Research Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has provided a written informed consent prior to any study-related procedure. 2) The patient is at least over 20 years and equal to below 90 years old. 3) The patient has a diagnosis of malignant tumor as confirmed by histopathology or cytology. 4) The patient has a diagnosis of malignant melanoma progressive melanoma in AJCC stage IIIC or stage IV who meets either below condition; #Recurrent #Refractory or inapplicable to a standard treatment #The patient refuses a standard treatment. 5) The patient has one or more administrationable lesion of HVJ-E solution on the skin, subcutis, or lymph node (less than 25 cm2 in size measured by forceps calipers, CT, or MRI review). 6) The patient has a life expectancy for at least 12 weeks or more. 7) The patient has a ECOG Performance Status Scale of 0 or 1. 8) The patient has measurable lesions (calipers, CT, or MRI review). 9) The organs function adequately evaluated by the following lab values; WBC: equal or more than 2,000/mL PLT: equal or more than 75,000/mL Hemoglobin: equal or more than 8.0 g/dL GOT: equal: or less than 100 IU/L GPT: equal or less than 100 IU/L T-Bil: equal or less than 2.5 mg/dL Serum creatinine: equal or less than 2.3mg/dL
Exclusion criteria
Exclusion criteria: 1) The patient has multiple brain metastases. 2) The patient shows positive immune response by HVJ-E prick test at screening. 3) The patient has a uncontrolled serious complication such as active infection. 4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks). 5) Participation in another clinical trial of another investigational medical product within 4 weeks. 6) History of a second independent malignancy within 2 years. 7) History of active autoimmune disease 8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisone over 6 months. 9) The patient is a pregnant or lactating female. 10) Clinically relevant psychiatric disorders/ legal incapacity or a limited legal capacity. 11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue. 12) Females with childbearing potential must have a positive b-HCG pregnancy test at screening. 13) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the safety and tolerability of inactivated HVJ-E | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessing the antitumor immunity and validity of inactivated HVJ-E | — |
Countries
Japan
Contacts
Public ContactRie Sumida, Tatsuhiro Hanai
Osaka University Hospital Medical Center for Translational Research
Outcome results
None listed