Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.
PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease|
- Response Rate [ Time Frame: 3 months ]
Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.
A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
- Grade 3 or Higher Non-hematologic Adverse Events [ Time Frame: Duration of treatment (up to 5 years) ]Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
- Overall Survival At 1 Year [ Time Frame: 1 year ]Percentage of patients who were alive at 1 year.
- Overall Survival At 2 Years [ Time Frame: 2 year ]Percentage of patients who were alive at 2 years.
- Pharmacokinetics [ Time Frame: At initiation of Tx and at 3 months ]
|Study Start Date:||December 2003|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
treatment of pts with refractory graft vs host disease
4 mg/sq m IV infusion over 20-30 min q 2 weeks
- Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.
- Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the infection rate in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the changes in lymphocyte populations in patients treated with this drug.
- Determine the survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.
Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074035
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, Illinois|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612-7243|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Union Hospital Cancer Program at Union Hospital|
|Elkton MD, Maryland, United States, 21921|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224-1791|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Sherif S. Farag, MD, PhD||Ohio State University|