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 '
- Conditions
- castration resistant prostate cancer
- Registration Number
- JPRN-UMIN000010840
- Lead Sponsor
- Department of Urology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 9
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess safety and tolerability of HVJ-E
- Secondary Outcome Measures
Name Time Method 1. To evaluate induction of tumor immunity 2. To evaluate anti-tumor effect