Clinical trial · Interventional
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2
Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Ineffectiveness
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Melanoma and Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irradiated donor lymphocyte infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-dose IL-2
- interventionNames
- Biological: Irradiated donor lymphocyte infusion
Primary outcomes (1)
- measure
- 12-week modified immune-related response rate
- timeFrame
- 12-week
Secondary outcomes (5)
- measure
- 6-week modified immune-related response rate
- timeFrame
- 6-week
- measure
- Overall response rate based on RECIST v1.1
- timeFrame
- 6/12-week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available