A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Both complete and partial response will be assessed
Sherif S. Farag, MD, PhD
Ohio State University
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|University of Illinois Cancer Center||Chicago, Illinois 60612-7243|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224-1791|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Union Hospital Cancer Program at Union Hospital||Elkton MD, Maryland 21921|