Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease

RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant.

PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer

OBJECTIVES:

I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD).

II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.

OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not.

GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity.

GROUP 2: Patients do not receive palifermin.

After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.

Inclusion Criteria:

• Survival for more than 60 days after an allogeneic hematopoietic cell transplantation (HCT) with growth-factor mobilized blood cells
• Current dose of prednisone at =< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment
• Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study
• Able and willing to give informed consent

Exclusion Criteria:

• Presence of generalized rash involving more than 50% of the body surface
• Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment
• Any prior local irradiation to a field that included the thymus (total body irradiation is allowed)
• History of thymectomy
• Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen
• Use of a graft depleted of T cells
• Any evidence of recurrent or persistent malignancy after HCT
• Participation in another study with chronic GVHD as the primary endpoint
• Any prior history of carcinoma
• Any infection that is not improving during appropriate treatment
• History of palifermin intolerance
• A positive pregnancy test (women of child-bearing potential)
• Breast feeding