Conditions: Graft Versus Host Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: treatment of pts with refractory graft vs host disease

Interventions: intervention 1: pentostatin
Intervention descriptions: intervention 1: 4 mg/sq m IV infusion over 20-30 min q 2 weeks

Protocol document: