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

NCT ID: NCT00530218

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2010-02-28

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.

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.

Conditions

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Leukemia; Lymphoma; Multiple Myeloma; MDS; Myelodysplastic/Myeloproliferative Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ganciclovir

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Cytovene

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo T. Spielberger, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

City of Hope National Medical Center

Duarte, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-98074

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000564546

Identifier Type: REGISTRY

Identifier Source: secondary_id

98074

Identifier Type: -

Identifier Source: org_study_id