search
Back to results

Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Primary Purpose

Metastatic Malignant Melanoma and Renal Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irradiated donor lymphocyte infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Malignant Melanoma and Renal Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-dose IL-2

Arm Description

Outcomes

Primary Outcome Measures

12-week modified immune-related response rate

Secondary Outcome Measures

6-week modified immune-related response rate
Overall response rate based on RECIST v1.1
Progression-free survival
Overall survival
Immune-related adverse events

Full Information

First Posted
August 14, 2013
Last Updated
April 22, 2016
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01925118
Brief Title
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Ineffectiveness
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Melanoma and Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose IL-2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Irradiated donor lymphocyte infusion
Primary Outcome Measure Information:
Title
12-week modified immune-related response rate
Time Frame
12-week
Secondary Outcome Measure Information:
Title
6-week modified immune-related response rate
Time Frame
6-week
Title
Overall response rate based on RECIST v1.1
Time Frame
6/12-week
Title
Progression-free survival
Time Frame
6-month
Title
Overall survival
Time Frame
1-year
Title
Immune-related adverse events
Time Frame
12-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

We'll reach out to this number within 24 hrs