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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Novartis
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00529035

Purpose

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.

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: Interleukin-2	Phase I

Drug Information available for: Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the feasibility and efficacy of administering an 8 week course of subcutaneous IL-2 in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in cGVHD. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	28
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
Patients must be at least 180 days from the allogeneic stem cell transplantation procedure
Steroid refractory cGVHD, defined as having persistent symptoms and signs of GVHD despite the use of prednisone for at least 4 weeks in the preceding 12 months without complete resolution of signs and symptoms.
Stable dose of corticosteroids for 4 weeks prior to enrollment
No addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.
Adequate bone marrow, renal and hepatic function as outlined in the protocol
18 years of age or older
ECOG Performance Status of 0-2

Exclusion Criteria:

Ongoing prednisone requirement > 1mg/kg/day (or equivalent)
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Concurrent ECP therapy within 4 weeks prior to enrollment
Post-transplant exposure to any novel immunosuppressive medication within 100 days prior to enrollment
Donor lymphocyte infusion within 100 days prior to IL-2 therapy
Active malignant disease relapse
Active, uncontrolled infection
Positive serologic test for Hepatitis B or a positive serologic or nucleic acid test for Hepatitis C
HIV seropositivity
Life expectancy < 3 months
Pregnancy or lactation
Inability to comply with IL-2 treatment regimen
Uncontrolled cardiac angina or symptomatic congestive heart failure
Organ transplant (allograft) recipient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529035

Contacts

Contact: John Koreth, MBBS, D.Phil.	617-632-2949	jkoreth@partners.org
Contact: Kimberly Phillips	617-632-6362	kimberly_phillips@dfci.harvard.edu

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Novartis

Investigators

Principal Investigator:

John Koreth, MBBS, D.Phil

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( John Koreth, MBBS, D.Phil )
Study ID Numbers:	07-083
Study First Received:	September 11, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00529035
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Chronic GVHD
Steroid refractory GVHD
allogeneic stem cell transplantation

Study placed in the following topic categories:

Interleukin-2
Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009