Refractory Urothelial or Prostate Cancer
Conditions
Interventions
Sponsors
Mie University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically documented i) urothelial or ii) prostate cancer. 2)Refractory to standard therapy. 3)NY-ESO-1 expression in tumor confirmed by immunohistochemistry or RT-PCR. 4)Life expectancy: >= 3 months from the date of consent. 5)Age: >= 20 years. 6)Performance status (ECOG scale): 0-2. 7)Adequate organ functions, measured as follows: White blood cells: >= 2,000/mm3 Hemoglobin: >= 8.0 g/dl Thrombocytes: >= 7.5 x 10000/mm3 Total birilbin: <= 1.5 x ULN Aspartate aminotransferase (AST, GOT): <= 3 x ULN Alanine aminotransferase (ALT, GPT): <= 3 x ULN Serum creatinine: <= 1.5 x ULN 8)Time from prior therapy: >= 2 weeks after the last administration date of prior chemotherapy. >= 2 weeks after the last radiation date of prior radiotherapy. >= 4 weeks after the date of last surgery. >= 4 weeks after the last treatment date of prior immunotherapy. 9)Cooperativeness to written informed consent must be obtained and documented.
Exclusion criteria
Exclusion criteria: 1)Past history of severe hypersensitivity. 2)Positive for HBs antigen, HCV antibody or HIV antibody. 3)Experience of autoimmune disease requiring treatment during 6 months preceding the day of consent. 4)Active multiple primaries. Simultaneous or metachronous with disease-free interval of 5 years or more. 5)Patient with disease requiring emergent radiotherapy. 6)Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosup-pressive drugs. 7)Patients with severe complication(s). 8)History of other NY-ESO-1-related immunotherapy. 9)Pregnant, lactating, or unprotected female. 10)Any other cases that the attending doctor judges not appropriate to enroll to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD), dose limiting toxicity (DLT) and adverse effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response, quality of life (EORTC QLQ-C30), and the change in serum PSA level (prostate cancer only) | — |
Countries
Japan
Outcome results
None listed