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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia; Multiple Myeloma; Myelodysplastic/Myeloproliferative Diseases; MDS; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
• Intervention / Treatment: Drug: Ganciclovir

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Study Participants; Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks	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; Other Names: Cytovene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ricardo T. Spielberger, MD, City of Hope Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 1999
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 13, 2007
• First Submitted That Met QC Criteria: September 13, 2007
• First Posted (Estimate): September 17, 2007

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: 98074; P30CA033572 (U.S. NIH Grant/Contract); CHNMC-98074 (Other Identifier: City of Hope National Medical Center); CDR0000564546 (Registry Identifier: NCI PDQ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO