Metastatic Malignant Melanoma and Renal Cell Carcinoma
Conditions
Brief summary
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.
Interventions
BIOLOGICALIrradiated donor lymphocyte infusion
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week modified immune-related response rate | 12-week |
Secondary
| Measure | Time frame |
|---|---|
| 6-week modified immune-related response rate | 6-week |
| Overall response rate based on RECIST v1.1 | 6/12-week |
| Progression-free survival | 6-month |
| Overall survival | 1-year |
| Immune-related adverse events | 12-week |
Countries
South Korea
Outcome results
None listed