Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients ' - Subsequent injection of HVJ-E

Department of Urology, Osaka University Graduate School of Medicine0 个研究点目标入组 9 人开始时间: 2013年6月1日最近更新: 2023年10月17日

适应症

试验速览

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•1. The patient who was 'progressive disease (PD)' assessed by PSA value in the "Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous infection of HVJ-E to castration resistant prostate cancer patients." 2. The patient who has brain metastases. 3. The patient who shows positive immune response by HVJ-E prick test at screening. 4. The patient who has a uncontrolled serious complication such as active infection. 5. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks. 6. The patient who has any active autoimmune diseases. 7. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months. 8. The patient who is undergoing on immunosuppressive agents. 9. The patient who has a history of a transplantation of the allogeneic organ. 10. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 11. The patient who is inappropriate to be enrolled in this trial judged by the doctors in charge.

发起方

Department of Urology, Osaka University Graduate School of Medicine