NCT00529035

Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease

A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.

Detailed description

* IL-2 will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels. * Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until week 8.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Interleukin-2	Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-06-01
• Completion: 2020-05-27
• First posted: 2007-09-14
• Last updated: 2020-07-01
• Results posted: 2014-01-29

Locations

1 site across 1 country: United States