Phase I/II clinical trial of inactivated HVJ-E administration for advanced malignant melanoma patients - HVJ-E01/Melanoma/OUH-MTR

Department of Dermatology Osaka University Graduate School of Medicine0 个研究点目标入组 6 人开始时间: 2009年8月26日最近更新: 2023年10月17日

试验速览

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•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.

发起方

Department of Dermatology Osaka University Graduate School of Medicine