Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 12 and over NCI UCLA-0307071 NCT00079222

Objectives

1. Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation.

Entry 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

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

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)

Expected Enrollment

A total of 150 patients (75 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Mary Territo, MD, Principal investigator		Ph: 310-825-7768; 888-798-0719

Registry Information
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
Trial Start Date		2004-01-29
Registered in ClinicalTrials.gov		NCT00079222
Date Submitted to PDQ		2004-01-29
Information Last Verified		2005-04-20
NCI Grant/Contract Number		P30-CA16042

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