Vorinostat to Prevent Graft Versus Host Disease Following Reduced Intensity, Related Donor Stem Cell Transplant
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
The proposed research study is to test the drug vorinostat, in a new use as an additional
medication, with other standard treatments for the prevention of severe acute graft versus
host disease (GVHD).
If this treatment is safe and effective, when combined with a reduced intensity transplant,
the research may achieve a more effective therapy for patients with high-risk, blood cell
related cancers.
All subjects will receive an identical, known treatment to test if the treatment is safe and
effective (a phase II trial). For patients to take part they must have a high-risk, blood
cell cancer, be suitable candidates to receive a reduced intensity transplant and have a
matched, related donor.
Adult subjects (age 18 years and older) will be considered as subjects provided, as detailed
in the protocol, they meet additional criteria and are not excluded from participating. About
fifty (50) subjects will be enrolled in this study at the University of Michigan.
Patients who receive blood stem cell transplants (HSCT), also called bone marrow transplants,
to treat their cancer are at risk for serious complications, which may sometimes be fatal.
The more common, serious ones are relapse (return of their disease), body organ injury from
the intensity of the chemotherapy given prior to their transplant, and a serious complication
called graft versus host disease (GVHD). GVHD is a form of rejection, where the transplanted
cells of the donor attack the recipient's body as foreign, and do damage to organs and
tissues.
To decrease the side effects of the chemotherapy given before a transplant, reduced intensity
treatment plans(regimens)have recently been developed at a number of transplant centers. A
decrease in the side effects of chemotherapy (called toxicities) has been achieved; however,
this success with "less intensive" treatments has been partially offset by less successful
results in controlling the patient's cancer.
As mentioned above, GVHD is a form of transplant rejection. GVHD can affect the digestive
system, skin, liver and other body systems. GVHD can increase the risk of infection. After a
matched, related donor stem cell transplant, GVHD when severe, is a major cause of
discomfort, organ damage, and even death. When a graft vs host reaction develops, but is kept
under control, studies show there may be a beneficial graft versus tumor effect, helping to
destroy tumor cells in the patient, and thus providing a more effective control of their
cancer.
The goal of this study is to try to maximize the potential benefits, of giving patients less
intense chemotherapy to reduce the toxic effects, letting the graft vs host effect help in
destroying tumor cells, but preventing acute severe GVHD by using the drug vorinostat,
combined with standard medicines, to reduce the chance of serious GVHD-related complications.