RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known whether itraconazole is more effective than fluconazole for preventing infections. PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow transplantation.

Condition	Treatment or Intervention	Phase
Leukemia Testicular Cancer ovarian epithelial cancer Lymphoma Breast Cancer Multiple Myeloma kidney tumor	Drug: fluconazole  Drug: itraconazole	Phase III

Further Study Details: 

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.

PROTOCOL 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).

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

Ages Eligible for Study:  13 Years and above

Criteria

PROTOCOL 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

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Study chairs or principal investigators

Kieren A. Marr,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000067050; FHCRC-1322.00; NCI-H99-0030
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003883
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08