Imatinib Mesylate to Treat Skin Changes in Patients With Chronic Graft-Versus-Host Disease

• INCLUSION CRITERIA:
• Sclerodermatous graft versus host disease (ScGVHD) manifesting after at least 100 days following allogeneic hematopoietic stem cell transplantation is considered diagnostic for chronic graft versus host disease (cGVHD) according to National Institutes of Health (NIH) cGVHD Consensus Statement diagnostic criteria.

This diagnosis can be made clinically or by histopathology. The diagnosis must be confirmed by the principal investigator (PI), or lead associate investigator (LAI).

Skin biopsies will be reviewed by the National Cancer Institute (NCI) Laboratory of Pathology to confirm the diagnosis of ScGVHD.

• Patients must have measurable limitation in range of motion, defined as ScGVHD with or without fasciitis, restricting range of motion (ROM) of at least one joint with a minimum deficit of 25 percent.
• Prior therapy: Patients must have cGVHD refractory to at least one treatment regimen for cGVHD.

One prior regimen must have included systemic corticosteroids at the equivalent prednisone dosing of 1mg/kg/day times 14 days.

Patients in whom calcineurin inhibitors or corticosteroids are medically contraindicated may also be eligible for enrollment.

Patients who have had stabilization of disease on calcineurin inhibitors or steroids, but in whom these medications cannot be tapered without disease flare are also eligible.

Patient must be on stable or tapering immunosuppressive regimen for at least one month.

• Age: 4 years of age or older at the time of enrollment. Lower age limit set by lower established age limit norms of ROM scores for measurement criteria.
• Life expectancy of greater than 6 months.
• Karnofsky greater than or equal to 60 percent.
• Patients must be platelet transfusion and growth factor independent at the time of study entry.

Patients must have adequate organ and marrow function as defined below. Patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin.

(Gilbert syndrome is found in 3-10 percent of the general population, and is characterized by mild, chronic unconjugated hyperbilirubinemia in the absence of liver disease or overt hemolysis).

• absolute neutrophil count greater than or equal to 1,000/mcL
• platelets greater than or equal to 50,000/mcL
• total bilirubin less than 3 times upper limit of normal
• aspartate aminotransferase (AST)serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT)serum glutamic pyruvic transaminase (SGPT) less than 5 times upper limit of normal
• creatinine age-adjusted within normal limits

OR

• creatinine clearance greater than 20mL/min/1.73 m^2 for adults and pediatric patients with body surface area (BSA) greater than 0.97 m^2 with creatinine levels above institutional normals and greater than or equal to 40 mL/min 1.73 m^2 for pediatric patients with BSA less than 0.97 m^2.
• Age less than 5 years old Maximum Serum Creatinine 0.8 mg/dL
• Age 5 or less than 10 years old Maximum Serum Creatinine 1.0 mg/dL
• Age 10 or less than 15 years old Maximum Serum Creatinine 1.2 mg/dL
• Age 15 years old or greater Maximum Serum Creatinine 1.5 mg/dL
• Normal cardiac function for age as determined by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) (normal left ventricular (LV) function as measured by ejection fraction or shortening fraction).
• The effects of imatinib mesylate on the developing human fetus at the recommended therapeutic dose are unknown.

For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for six months following completion of therapy.

Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

All patients or their legal guar