Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients - Clinical study of intratumoral and subcutaneous injection of HVJ-E to CRPC patients

Department of Urology, Osaka University Graduate School of Medicine0 sites12 target enrollmentSeptember 1, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Castration resistant prostate cancer
Sponsor: Department of Urology, Osaka University Graduate School of Medicine
Enrollment: 12
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 1, 2011

End Date

July 1, 2014

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Department of Urology, Osaka University Graduate School of Medicine

•1\. The patient who has brain metastases. 2\. The patient who shows positive immune response by HVJ\-E prick test at screening. 3\. The patient who has a uncontrolled serious complication such as active infection. 4\. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks. 5\. The patient who participated in another clinical trial of another investigational medical product within 4 weeks. 6\. The patient who has history of second independent malignancy within 2 years. 7\. The patient who has any active autoimmune diseases. 8\. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months. 9\. The patient who is undergoing on immunosuppressive agents. 10\. The patient who has clinically relevant psychiatric disorders/ legal incapacity or limited legal capacity. 11\. The patient who has a history of a transplantation of the allogeneic organ. 12\. The patent who has inadequate blood property with PT and APTT more than 1\.5 times of the upper limit of local reference range. 13\. The patient who in inappropriate to be enrolled in this trial judged by the doctors in charge.