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.
OBJECTIVES: Primary * Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin. Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
4 mg/sq m IV infusion over 20-30 min q 2 weeks
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Response Rate
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.
Time frame: 3 months
Grade 3 or Higher Non-hematologic Adverse Events
Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
Time frame: Duration of treatment (up to 5 years)
Overall Survival At 1 Year
Percentage of patients who were alive at 1 year.
Time frame: 1 year
Overall Survival At 2 Years
Percentage of patients who were alive at 2 years.
Time frame: 2 year
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