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

City of Hope

Status and phase: Completed; Phase 2

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

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00530218

CDR0000564546 (Registry Identifier)

98074

CHNMC-98074 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

All Study Participants

Experimental group

Description:

Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks

Treatment:

Drug: Ganciclovir