A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose level and toxicity profile of an 8 week course of IL-2 in patients with cGVHD and an inadequate response to steroids.
John Koreth, MBBS, D.Phil
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|