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

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

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.

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.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Breast Cancer

Intervention

pentostatin

Location

Tunnell Cancer Center at Beebe Medical Center
Lewes
Delaware
United States
19958

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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