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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530218
• Other study ID #: 98074
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2007
• Last updated: October 25, 2017
• Start date: March 1999
• Est. completion date: February 2010

Study information

• Verified date: October 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• MDS
• Multiple Myeloma
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
• Myeloproliferative Disorders

Intervention

Drug:
• Ganciclovir
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

Locations

Country	Name	City	State
United States	City of Hope National Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

R. Spielberger, J. Zaia, R. A. Nelson, E. Newman, G. Gallez-Hawkins, A. Ahlers, J. Stevenson, C. Acedo, A. Alam, R. Bhatia, S. Cohen, P. Falk, H. Fung, A.Kashyap, N. Kogut, Al Krishnan, A. Molina, A. Nademanee, M. O'Donnell, P. Parker, L. Popplewell, R. Rodriguez, F. Sahebi, D. Snyder, A. Stein, S. Forman. Use of Oral Ganciclovir (PO-GCV) for the Preemptive Treatment (Tx) of CMV Following Allogeneic HCT: Safety and Feasibility Results. Blood 96 (11): 586A # 2516, 2000.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant
Primary	Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment		Twice Weekly after day 21 post-transplant
Primary	Compliance Rate Among Patients With CMV Reactivation	CMV reactivation patients completed 6-week GCV therapy.	From first ganciclovir positive test to the end of the 6th week GCV therapy