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

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ClinicalTrials.gov Identifier: NCT00530218
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : December 1, 2017
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Leukemia Lymphoma Multiple Myeloma MDS Myelodysplastic/Myeloproliferative Diseases Drug: Ganciclovir Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 1999
Primary Completion Date : February 2010
Study Completion Date : February 2010


Arms and Interventions

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 Name: Cytovene


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant ]
    This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.

  2. 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 ]
  3. Compliance Rate Among Patients With CMV Reactivation [ Time Frame: From first ganciclovir positive test to the end of the 6th week GCV therapy ]
    CMV reactivation patients completed 6-week GCV therapy.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530218


Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ricardo T. Spielberger, MD City of Hope Comprehensive Cancer Center
More Information

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.

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00530218     History of Changes
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 )
First Posted: September 17, 2007    Key Record Dates
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Multiple Myeloma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action