Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Seoul National University

Status and phase: Terminated; Phase 2

Conditions: Metastatic Malignant Melanoma and Renal Cell Carcinoma

Treatments: Biological: Irradiated donor lymphocyte infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01925118

H-1305-6130491

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

High-dose IL-2

Experimental group

Treatment:

Biological: Irradiated donor lymphocyte infusion