Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)

PHASE3CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

September 30, 2006

Study Completion Date

September 30, 2007

Conditions
LymphomaInfectionLeukemia
Interventions
DRUG

Fluconazole

Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients \> 12 years. For adults, each 200 mL infusion will be administered over 2 hours. In patients \< 12 years, intravenous doses will be prepared.

DRUG

Voriconazole

Voriconazole will be administered orally twice daily. Voriconazole capsules should be taken at least one hour before or one hour after a meal. Taken concomitantly with food, bioavailability of voriconazole is reduced. If oral drug is not possible, it will be given intravenously at a dosage of 200 mg every 12 hours over two hours in patients \> 12 years. Each voriconazole dose will be diluted to a total volume of 200 mL in patients \> 12 years. Volumes of the formulation required to provide 4 mg/kg doses for children age \< 12 years.

Trial Locations (33)

10021

Memorial Sloan-Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

19104

Children's Hospital of Philadelphia, Philadelphia

University of Pennsylvania Cancer Center, Philadelphia

20010

Children's National Medical Center, Washington D.C.

21231

Johns Hopkins/SKCCC, Baltimore

27157

Wake Forest University Health Sciences, Winston-Salem

27705

Duke University Medical Center, Durham

32610

University of Florida College of Medicine (Shands), Gainesville

33624

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama at Birmingham, Birmingham

44106

University Hospitals of Cleveland/Case Western, Cleveland

46202

Indiana University Medical Center, Indianapolis

48109

University of Michigan Medical Center, Ann Arbor

48201

Karmanos Cancer Institute/BMT, Detroit

55455

University of Minnesota, Minneapolis

60614

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Cardinal Glennon Children's Hospital, St Louis

Washington University/Barnes Jewish Hospital, St Louis

Washington University/St. Louis Children's Hospital, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

64111

Kansas City Cancer Centers, Kansas City

68198

University of Nebraska Medical Center, Omaha

77030

University of Texas/MD Anderson CRC, Houston

78229

Texas Transplant Institute, San Antonio

84132

Utah BMT/Univ of Utah Med School, Salt Lake City

92093

UCSD Medical Center, La Jolla

94305

Stanford Hospital and Clinics, Stanford

97239

Oregon Health Sciences University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

02114

Dana Farber Cancer Institute/Brigham & Womens, Boston

Dana Farber Cancer Institute/Children's Hospital of Boston, Boston

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

lead

Medical College of Wisconsin

OTHER

NCT00075803 - Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) | Biotech Hunter | Biotech Hunter