Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

April 22, 2016 updated by: Dae Seog Heo, Seoul National University Hospital

Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High-dose IL-2
Biological: Irradiated donor lymphocyte infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-week modified immune-related response rate
Time Frame: 12-week
12-week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (ESTIMATE)

August 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1305-6130491

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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