Metastatic Malignant Melanoma and Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
| Verified date | April 2016 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Histologically confirmed malignant melanoma or renal cell carcinoma - At stage IV or relapse - At least one prior chemotherapy including targeted agents - At least one haploidential or partially matched-HLA donor - ECOG performance status 0-1 - Age 18-75 years - Measurable lesion - Adequate bone marrow, liver, and renal functions Exclusion Criteria: - Chemotherapy within 4 weeks - Stem cell transplantation - Active CNS metastasis - Hypersensitivity to IL-2 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 12-week modified immune-related response rate | 12-week | No | |
| Secondary | 6-week modified immune-related response rate | 6-week | No | |
| Secondary | Overall response rate based on RECIST v1.1 | 6/12-week | No | |
| Secondary | Progression-free survival | 6-month | No | |
| Secondary | Overall survival | 1-year | No | |
| Secondary | Immune-related adverse events | 12-week | Yes |