Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor 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.
Chronic Myeloproliferative Disorders
Multiple Myeloma and Plasma Cell Neoplasm
Other: pharmacological study
Procedure: allogeneic hematopoietic stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Study of Intravenous Ganciclovir Followed by Oral Ganciclovir in the Treatment of Reactivation of CMV Following Bone Marrow Transplant|
- Patient compliance with an oral ganciclovir (GCV) regimen following induction with IV GCV as measured by a self-recorded patient diary and number of adverse events
- Observation of cytomegalovirus (CMV) in blood as measured by either blood culture or polymerase chain reaction (PCR) during the course of antiviral treatment
- Rate of CMV-associated disease that occurs during or after treatment
- Rate of CMV blood infection that occurs after treatment and during the period to day 180
- GCV blood levels
- Correlation of the GCV pharmacokinetic data with clinical outcome
- Practical ability to utilize PCR-based decisions
|Study Start Date:||March 1999|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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.
- To evaluate the clearance of CMV as measured by quantitative plasma polymerase chain reaction (PCR) using this schema of treatment.
- To establish the feasibility of measuring steady state GCV blood levels in patients on oral GCV.
- To correlate GCV pharmacokinetic data with clinical outcome of these patients.
- To explore the feasibility of a CMV management guideline that incorporates PCR results in clinical decision making.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530218
|Principal Investigator:||Ricardo T. Spielberger, MD||Beckman Research Institute|