Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease After Donor Stem Cell Transplant

Inclusion Criteria:

• Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes > 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
• Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
• All subjects must provide written informed consent with the use of forms approved by the FHCRC IRB

Exclusion Criteria:

• Significant renal dysfunction (estimated creatinine clearance < 30 mL/min)
• Persistent or recurrent malignancy
• Secondary malignancy
• Patients who had autologous or syngeneic marrow transplantation
• Presence of any cause of intestinal symptoms or ulceration other than GVHD
• Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded