Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

2014-08-27 03:54:45 | BioPortfolio


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.




- 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.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care


Breast Cancer




Tunnell Cancer Center at Beebe Medical Center
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:54:45-0400

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