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

NCT00530218 | Completed Phase 2 Results DMC

• 4 other identifiers: 98074P30CA033572CHNMC-98074CDR0000564546
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

All Study Participants

EXPERIMENTAL

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

Interventions

Ganciclovir 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

Also known as: Cytovene

All Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic-Myeloproliferative Diseases

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ricardo Spielberger, MD
• Organization: City of Hope National Medical Center

RSpielberger@coh.org

626-359-8111

Study Officials

• Ricardo T. Spielberger, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: March 1, 1999
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)