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

Alternate Title

Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 13 and over NCI FHCRC-1322.00 NCI-H99-0030, NCT00003883

Objectives

I.  Compare the efficacy of itraconazole versus fluconazole in reducing the 
incidence of breakthrough Aspergillus infections in patients undergoing 
allogeneic peripheral blood stem cell or bone marrow transplantation.

II.  Compare the incidence of combined mold/yeast infections and the use of 
alternative systemic antifungal treatments in these patients on this regimen.

III.  Compare the toxic effects of these two drugs in these patients.

IV.  Determine the survival rate of these patients.

Entry Criteria

Disease Characteristics:

Scheduled to undergo allogeneic peripheral blood stem cell, bone marrow, or
cord blood transplant (except minitransplant)

No documented or suspected invasive fungal infection

Prior/Concurrent Therapy:

Biologic therapy:
 See Disease Characteristics

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No prior nonmyeloablative regimen (e.g., FHCRC-1209 or FHCRC-1225)
 No other concurrent antifungal agents
 No concurrent astemizole, terfenadine, or cisapride
 

Patient Characteristics:

Age:
 13 and over

Performance status:
 Not specified

Life expectancy:
 More than 2 weeks

Hematopoietic:
 Not specified

Hepatic:
 Bilirubin no greater than 5 times upper limit of normal (ULN) OR
 AST or ALT no greater than 5 times ULN OR
 Alkaline phosphatase no greater than 5 times ULN

Renal:
 Not specified
 
Other:
 Weight at least 40 kg
 Fertile patients must use effective contraception
 No history of anaphylaxis due to azole antifungal drug compounds
 No uncontrolled bacteremia
 No concurrent condition that would preclude study

Expected Enrollment

A total of 578 patients (289 per arm) will be accrued for this study within 4 
years.

Outline

This is a randomized study.  Patients are randomized to one of two treatment 
arms.

Arm I:  Patients receive fluconazole orally or IV daily beginning at start of 
conditioning regimen and continuing until day 180 or until 4 weeks after 
stopping corticosteroids (if it occurs between days 120-180).

Arm II:  Patients receive oral fluconazole daily beginning at start of 
conditioning regimen and continuing until day 0.  Patients then receive 
itraconazole orally or IV daily beginning on day 0 and continuing until day 
180, or until 4 weeks after stopping corticosteroids (if it occurs between 
days 120-180).

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Kieren A. Marr, MD, Protocol chair		Ph: 206-667-2995

Registry Information
Official Title		A Randomized, Comparative Study of Itraconazole Versus Fluconazole for Prevention of Aspergillus Infections in Peripheral Blood Stem Cell and Marrow Transplant Recipients
Trial Start Date		1998-10-19
Registered in ClinicalTrials.gov		NCT00003883
Date Submitted to PDQ		1999-04-30
Information Last Verified		2007-07-11
NCI Grant/Contract Number		CA18029, CA15704

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