Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Closed | 12 and over | NCI, Other | CDR0000355116 UCLA-0307071, NCT00079222 |
Summary
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.
Further Study Information
OBJECTIVES:
- Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation.
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.
- Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT), patients receive voriconazole IV twice daily on days 1-14 and then orally* twice daily on days 15-100.
- Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days 1-2, once daily on days 3-14, and then orally* twice daily on days 15-100.
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 Criteria
DISEASE CHARACTERISTICS:
- Undergoing allogeneic hematopoietic stem cell transplantation
- No invasive yeast infection within the past 8 weeks
- Colonized or superficial infection allowed
- No documented or probable aspergillus or mold infection within the past 8 weeks
- Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia
PATIENT CHARACTERISTICS:
Age
- 12 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 1 week since prior amphotericin B or fluconazole for candidemia
- No concurrent therapy with any of the following:
- Rifampin
- Rifabutin
- Phenobarbital
- Phenytoin
- Carbamazepine
- Oral midazolam
- Triazolam
- Terfenadine
- Astemizole
- Concurrent topical antifungal agents for superficial fungal infections allowed
Trial Lead Organizations/Sponsors
Jonsson Comprehensive Cancer Center at UCLA
National Cancer Institute| Mary Carol Territo |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00079222
Information obtained from ClinicalTrials.gov on December 14, 2011
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