malignant melanoma malignamt melanoma, advanced stage
Conditions
Interventions
Test drug (T-hIL12) will be administered into the tumor of skin or lymph node metastases in subjects with advanced stage of malignant melanoma. The assigned dose will be repeatedly inoculated into the
T-hIL12, intratumoral administration
Sponsors
Okuyama Ryuhei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (Phase 1) 1) Histologically confirmed malignant melanoma with stage 3 or 4. 2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/or at least one metastatic lymph node with 15 mm or larger (the shortest axis). 3) Patients who were administered with anti-PD-1 antibody and/or molecular targeted drugs. 4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI). 5) Age >=20 years 6) More than 30 days have passed from the previous treatment. 7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2. 8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction). (Phase 2) 1) Histologically confirmed malignant melanoma with stage 3 or 4. 2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/ or at least one metastatic lymph node with 15 mm or larger (the shortest axis). 3) Patients who have not been administered with anti-PD-1 antibody or molecular targeted drugs. 4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI). 5) Age >=20 years. 6)More than 30 days have passed from the previous treatment. 7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-1. 8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction).
Exclusion criteria
Exclusion criteria: (Phase 1 and 2) 1) Patients who have brain and/or spinal cord metastases. 2)Estimated survival period 10mg of prednisolone or immunosuppressants. 12) Patients who were administered with other clinical trial drugs within 30 days of T-hIL12 administration. 13) Patients who had oncolytic virus therapy before. 14) Patients who are in conditions considered inadequate for the subject to be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Phase 1 part) Safety (Phase 2 part) Response rate (RECIST 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Phase 1 part) 1) Response rate (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy) 2) Overall survival 3) Progression-free survial (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy) 4) Tumor reduction effects on cutaneous and/or subcutaneous lesions, or lymph nodes inoculated with T-hIL12 (Phase 2 part) 1) Response rate (Response evaluation criteria for oncolytic virus therapy) 2) Safety 3) Overall survival 4) Progression-free survial (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy) 5) Tumor reduction effects on cutaneous and/or subcutaneous lesions, or lymph nodes inoculated with T-hIL12 | — |
Contacts
Public ContactKazuhiko Matsumoto
Shinshu University Hospital
Outcome results
None listed