A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Response rate
Both complete and partial response will be assessed
3 months
No
Sherif S. Farag, MD, PhD
Study Chair
Ohio State University
United States: Federal Government
CDR0000341678
NCT00074035
December 2003
March 2013
Name | Location |
---|---|
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 |