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Home > "V" Clinical Trials Conditions > Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation  Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
For Condition: Infection,Cancer
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomizedphase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
Details: OBJECTIVES: - Compare the occurrence of serious invasive fungal or bacterial infections during the first 270 days after transplantation in cytomegalovirus (CMV)-negative patients receiving a CMV-positive allogeneic stem cell transplantation and valacyclovir or placebo. - Compare the occurrence of primary CMV infection within the first 100 days after transplantation in patients treated with these regimens. - Compare the survival of these patients at 100 days and 270 days post-transplantation. - Compare the occurrence of CMV disease at day 100 and day 270 post-transplantation in patients treated with these regimens. - Compare the safety of these regimens in these patients. - Correlate the presence of CMV in stem cell product with post-transplantation CMV infection in these patients. - Determine if subclinical CMV infection results in a virus-specific immune response (humoral and cellular) in these patients. - Compare the quality of life of patients treated with these regimens. - Compare resource utilization (e.g., rates of hospitalization, number of days alive out of the hospital, days in the intensive care unit, days on mechanical ventilation, use of antimicrobials and filgrastim [G-CSF], and number of invasive procedures) in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of transplantation (matched related vs mismatched/unrelated). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral valacyclovir 4 times daily beginning with transplantation conditioning (usually day -5) and continuing until day 100 after transplantation. Patients receive high-dose acyclovir, instead of valacyclovir, IV every 8 hours beginning on day -1 and continuing until oral medications are tolerated. Allogeneic stem cells are infused on day 0. - Arm II: Patients receive oral or IV placebo on the same schedule as in arm I. Quality of life is assessed at baseline and on days 50 and 100. Patients are followed every 2 weeks for 6 months. PROJECTED ACCRUAL: A total of 115-230 patients (58-115 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Disease requiring one of the following types of stem cell transplantation: - First myeloablative allogeneic peripheral blood stem cell - Unrelated cord blood - Bone marrow - Related or unrelated donor - T-cell depleted or non-T-cell depleted - CD34 selected or non-selected - Patient must be cytomegalovirus (CMV)-seronegative and donor must be CMV-seropositive - No transplantation with nonmyeloablative regimens, including any of the following: - Fludarabine and total body irradiation (TBI) (2 Gy or less) - TBI alone (2 Gy) - Fludarabine, cytarabine, and idarubicin - Fludarabine and melphalan (140 mg/m^2 or less) - No definite or probable pre-transplantation diagnosis of invasive mold infection (aspergillosis, fusariosis, or zygomycosis), including pulmonary or hepatic nodules consistent with invasive mold infection for which patients are receiving targeted prophylaxis with amphotericin or other mold-active products - No pre-transplantation-CMV disease (gastrointestinal or pneumonia) PATIENT CHARACTERISTICS: Age - 12 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - HIV negative - No hypersensitivity to acyclovir or valacyclovir - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarrettNichols, Study Chair, Fred Hutchinson Cancer Research Center
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: CDR0000256871; FHCRC-1603.00,NCI-H02-0092
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045292
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Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
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