Overview

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

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Lithium Carbonate
Criteria
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 Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (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