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”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: itraconazole
• Drug: voriconazole

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Jonsson Comprehensive Cancer Center

Overall Clinical Trial Officials and Contacts

Mary C. Territo, MD Principal Investigator Jonsson Comprehensive Cancer Center  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00079222

Study ID Number: CDR0000355116

ClinicalTrials.gov Identifier: NCT00079222

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database