Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/3/2017
Start Date:March 1999
End Date:February 2010

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Phase II Study of Intravenous Ganciclovir Followed by Oral Ganciclovir in the Treatment of Reactivation of CMV Following Bone Marrow Transplant

RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by
infusion and then by mouth may be effective treatment for cytomegalovirus that has become
active after donor bone marrow transplant.

PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth
works in treating patients with cytomegalovirus after donor bone marrow transplant.

OBJECTIVES:

- To determine the feasibility of using oral ganciclovir (GCV) following induction with
intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow
transplantation.

OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the planned
bone marrow transplantation (BMT). Patients showing reactivation of CMV receive induction
ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance oral GCV
three times a day for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacokinetic studies.

Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Undergoing allogeneic transplantation, including unrelated donor bone marrow
transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication

- Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV)
antibody titer as measured by enzyme-linked immunosorbent assay (ELISA)

PATIENT CHARACTERISTICS:

- Able to comply with study requirements

Exclusion criteria:

- Signs or symptoms of documented CMV infection, including any positive CMV culture from
any site and/or any suspected or documented CMV-associated clinical syndrome, at the
time of study entry

- History of symptomatic CMV-associated clinical syndrome

PRIOR CONCURRENT THERAPY:

- Receiving concurrent investigational antiviral agents

PATIENT CHARACTERISTICS:

- History of hypersensitivity to ganciclovir or acyclovir
We found this trial at
1
site
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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