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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079222 |
Purpose
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
| Condition | Intervention |
|
Cancer |
Drug: itraconazole Drug: voriconazole |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Fungal Infections Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Molds Multiple Myeloma |
| Drug Information available for: | Itraconazole Clotrimazole Miconazole Miconazole nitrate Tioconazole Voriconazole |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Randomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients |
| Study Start Date: | January 2004 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to donor type (related vs unrelated). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients unable to tolerate oral medication may continue IV medication beyond day 14.
In both arms, treatment continues in the absence of unacceptable toxicity or an invasive fungal infection. Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100.
Patients are followed until day 180 post-transplantation.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No invasive yeast infection within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapy with any of the following:
Contacts and Locations| United States, California | |||||
| Jonsson Comprehensive Cancer Center, UCLA | |||||
| Los Angeles, California, United States, 90095-1678 | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Mary C. Territo, MD | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000355116, UCLA-0307071 |
| First Received: | March 8, 2004 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079222 |
| Health Authority: | United States: Federal Government |
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