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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
61
Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks
City of Hope National Medical Center
Duarte, California, United States
Number of Participants With Adverse Events
This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.
Time frame: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant
Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment
Time frame: Twice Weekly after day 21 post-transplant
Compliance Rate Among Patients With CMV Reactivation
CMV reactivation patients completed 6-week GCV therapy.
Time frame: From first ganciclovir positive test to the end of the 6th week GCV therapy
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