Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Phase 2

Terminated

• Conditions: Metastatic Malignant Melanoma and Renal Cell Carcinoma
• Interventions: Biological: Irradiated donor lymphocyte infusion

• Registration Number: NCT01925118
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

• Chemotherapy within 4 weeks
• Stem cell transplantation
• Active CNS metastasis
• Hypersensitivity to IL-2

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-dose IL-2	Irradiated donor lymphocyte infusion	-

Primary Outcome Measures

Name	Time	Method
12-week modified immune-related response rate	12-week

Secondary Outcome Measures

Name	Time	Method
Immune-related adverse events	12-week
Overall response rate based on RECIST v1.1	6/12-week
Progression-free survival	6-month
Overall survival	1-year
6-week modified immune-related response rate	6-week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of