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Caspofungin versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

Trial Status: Complete

This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for prophylaxis in children is not known. Caspofungin has activity against yeast and some molds while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that agents with activity against yeasts and molds are more effective than those with just activity against yeasts. There are limited data to answer this comparative question in children. This study will establish much needed pediatric data to guide clinical decision making on optimal antifungal prophylaxis.

Inclusion Criteria

  • Patients must have one of the following diagnoses and/or treatment plans: * Newly diagnosed de novo AML * First or subsequent relapse of AML * Secondary AML * Treatment with institutional standard AML therapy in those without AML (for example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia) * Note: Patients with a history of prolonged antifungal therapy (example, relapsed AML) are eligible
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows: * =< 0.4 mg/dL (age 1 month to < 6 months) * =< 0.5 mg/dL (age 6 months to < 1 year) * =< 0.6 mg/dL (age 1 to < 2 years) * =< 0.8 mg/dL (age 2 to < 6 years) * =< 1 mg/dL (age 6 to < 10 years) * =< 1.2 mg/dL (age 10 to < 13 years) * =< 1.4 mg/dL (females age >= 13 years) * =< 1.5 mg/dL (males age 13 to < 16 years) * =< 1.7 mg/dL (males age >= 16 years)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age AND Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age
  • All patients and/or their parents or legal guardians must sign a written informed consent

Exclusion Criteria

  • Patients with the following diagnoses are not eligible: * Acute promyelocytic leukemia (APL) * Down syndrome * Juvenile myelomonocytic leukemia (JMML)
  • Patients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligible
  • Patients with a history of echinocandin or fluconazole hypersensitivity are not eligible
  • Patients receiving treatment for an IFI are not eligible
  • Female patients of childbearing age must have a negative pregnancy test
  • Patients must agree to use an effective birth control method
  • Lactating patients must agree not to nurse a child while on this trial

Alabama

Birmingham
Children's Hospital of Alabama
Status: CLOSED_TO_ACCRUAL
Contact: Alyssa Terry Reddy
Phone: 205-638-9285
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alyssa Terry Reddy
Phone: 205-638-9285

Arizona

Phoenix
Phoenix Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jessica Boklan
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David L. Becton
Phone: 501-364-7373
University of Arkansas for Medical Sciences
Status: CLOSED_TO_ACCRUAL
Contact: David L. Becton
Phone: 501-364-7373

California

Downey
Kaiser Permanente Downey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert Michael Cooper
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: CLOSED_TO_ACCRUAL
Contact: Pamela Helen-heilge Kempert
Phone: 562-933-5600
Los Angeles
Cedars Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: CLOSED_TO_ACCRUAL
Contact: Leo Mascarenhas
Phone: 323-361-4110
Madera
Valley Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Vonda Lee Crouse
Phone: 866-353-5437
Oakland
Kaiser Permanente-Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Steven K. Bergstrom
Phone: 626-564-3455
Orange
Children's Hospital of Orange County
Status: CLOSED_TO_ACCRUAL
Contact: Violet Shen
Phone: 714-997-3000
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: CLOSED_TO_ACCRUAL
Contact: William D. Roberts
Phone: 858-966-5934
San Francisco
UCSF Medical Center-Mission Bay
Status: CLOSED_TO_ACCRUAL
Contact: Mignon Lee-Cheun Loh
Phone: 877-827-3222
UCSF Medical Center-Parnassus
Status: CLOSED_TO_ACCRUAL
Contact: Mignon Lee-Cheun Loh
Phone: 877-827-3222
Torrance
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Joseph L. Lasky
Phone: 888-662-8252

Colorado

Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jennifer Jocelyn Clark
Phone: 866-775-6246

Connecticut

Hartford
Connecticut Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael Scott Isakoff
Phone: 860-545-9981
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529

District of Columbia

Washington
Children's National Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Stuart Dome
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Amal Mousa Abu-Ghosh
Phone: 202-444-0381

Florida

Fort Lauderdale
Broward Health Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: CLOSED_TO_ACCRUAL
Contact: Emad K. Salman
Phone: 239-343-5333
Lee Memorial Health System
Status: CLOSED_TO_ACCRUAL
Contact: Emad K. Salman
Phone: 239-343-5333
Gainesville
University of Florida Health Science Center - Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: William Birdsall Slayton
Phone: 352-273-8675
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Iftikhar Hanif
Phone: 954-265-2234
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Orlando
AdventHealth Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Fouad M. Hajjar
Phone: 407-303-2090
Nemours Children's Clinic - Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Nemours Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Orlando Health Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Pensacola
Nemours Children's Clinic - Pensacola
Status: CLOSED_TO_ACCRUAL
Contact: Scott M. Bradfield
Phone: 904-697-3529
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Alan Hale
Phone: 727-767-2423
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: CLOSED_TO_ACCRUAL
Contact: Mark J. Mogul
Phone: 800-882-4123
Tampa General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Cameron K. Tebbi
Phone: 800-882-4123
West Palm Beach
Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Narayana Gowda

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: CLOSED_TO_ACCRUAL
Contact: Glen Lew
Phone: 404-785-1112
Savannah
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: J. Martin Johnston
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: CLOSED_TO_ACCRUAL
Contact: Wade T. Kyono
Phone: 808-983-6090
University of Hawaii Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert W. Wilkinson
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Eugenia Chang
Phone: 208-381-3376

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: CLOSED_TO_ACCRUAL
Contact: David O. Walterhouse
Phone: 773-880-4562
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Susan Lerner Cohn
Phone: 773-834-7424
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: CLOSED_TO_ACCRUAL
Contact: Rebecca Erin McFall
Phone: 847-723-7570
Springfield
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Robert J. Fallon
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Bassem I. Razzouk
Phone: 317-338-2194

Iowa

Des Moines
Blank Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-6729
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth G. Lucas
Phone: 866-530-5516

Louisiana

New Orleans
Children's Hospital New Orleans
Status: CLOSED_TO_ACCRUAL
Contact: Lolie C. Yu
Phone: 504-894-5377
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Craig Lotterman
Phone: 888-562-4763
Tulane University Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Tammuella Chrisentery Singleton
Phone: 504-988-6121

Maine

Bangor
Eastern Maine Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Sam Wei Lew
Phone: 800-987-3005

Maryland

Baltimore
Sinai Hospital of Baltimore
Status: CLOSED_TO_ACCRUAL
Contact: Jason M. Fixler
Phone: 410-601-6120
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Teresa Anne York
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Anne Benedicta Warwick
Phone: 301-319-2100

Massachusetts

Boston
Tufts Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Michael J. Kelly
Phone: 617-636-5000

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rajen Mody
Phone: 800-865-1125
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Hadi Sawaf
Phone: 313-343-3166
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Meret Henry
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: CLOSED_TO_ACCRUAL
Contact: Renuka Gera
Phone: 517-975-9547
Flint
Hurley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Nkechi Onwuzurike
Phone: 888-606-6556
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: CLOSED_TO_ACCRUAL
Contact: David Scott Dickens
Phone: 616-391-1230
Kalamazoo
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230
Kalamazoo Center for Medical Studies
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey S. Lobel
Phone: 616-391-1230
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Laura Kate Gowans
Phone: 248-551-7695

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: CLOSED_TO_ACCRUAL
Contact: Michael Kerr Richards
Phone: 612-813-5193
University of Minnesota / Masonic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Peter Michael Gordon
Phone: 612-624-2620
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Carola A. S. Arndt
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: CLOSED_TO_ACCRUAL
Contact: Barbara Anne Gruner
Phone: 573-882-7440
University of Missouri - Ellis Fischel
Status: WITHDRAWN
Contact: Thomas Ward Loew
Phone: 573-882-7440
Kansas City
Children's Mercy Hospitals and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Maxine Lorraine Hetherington
Phone: 816-234-3265
Saint Louis
Cardinal Glennon Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: William Shay Ferguson
Phone: 314-268-4000
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Bethany Graham Sleckman
Phone: 913-948-5588
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Robert J. Hayashi
Phone: 800-600-3606

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: CLOSED_TO_ACCRUAL
Contact: Minnie Abromowitch
Phone: 402-955-3949
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Minnie Abromowitch
Phone: 402-955-3949

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation NCORP
Status: ACTIVE
Contact: Jonathan Bernstein
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Sara Chaffee
Phone: 800-639-6918

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven H. Diamond
Phone: 201-996-2879
Livingston
Saint Barnabas Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Stacey Rifkin-Zenenberg
Phone: 973-322-2470
Morristown
Morristown Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nibal Ahmad Zaghloul
Phone: 732-745-8600ext6163
Newark
Newark Beth Israel Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Peri Kamalakar
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mary Ann Bonilla
Phone: 973-754-2909
Summit
Overlook Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Steven Lon Halpern
Phone: 973-971-5900

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Koh B. Boayue
Phone: 505-925-0366

New York

Albany
Albany Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Benjamin Gill
Phone: 718-904-2730
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Barbara J. Bambach
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mark E. Weinblatt
Phone: 866-946-8476
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: CLOSED_TO_ACCRUAL
Contact: Mark P. Atlas
Phone: 718-470-3470
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Sharon Leigh Gardner
Phone: 212-263-4434
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alice Lee
Phone: 212-305-8615
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert Ingalls Parker
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Melanie A. Comito
Phone: 315-464-5476
Valhalla
New York Medical College
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Fevzi Ozkaynak
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Stuart Harrison Gold
Phone: 877-668-0683
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Joel A. Kaplan
Phone: 704-355-2884
Novant Health Presbyterian Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jessica Amy Fu Bell
Phone: 704-384-5369
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Susan G. Kreissman
Phone: 888-275-3853
Greenville
East Carolina University
Status: CLOSED_TO_ACCRUAL
Contact: George Edward Hucks
Phone: 252-744-2391
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Samuel Odame Anim
Phone: 701-234-6161

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: CLOSED_TO_ACCRUAL
Contact: Steven J. Kuerbitz
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rajaram Nagarajan
Phone: 513-636-2799
Cleveland
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mark Anthony Ranalli
Phone: 614-722-2708
Dayton
Dayton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ayman Aly El-Sheikh
Phone: 800-228-4055
Toledo
Mercy Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rama Jasty
Phone: 800-865-1125
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Rene Y McNall-Knapp
Phone: 405-271-8777
Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Brian Kirkpatrick
Phone: 918-494-2200

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Janice Faye Olson
Phone: 503-413-2560
Legacy Emanuel Hospital and Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Janice Faye Olson
Phone: 503-413-2560
Oregon Health and Science University
Status: CLOSED_TO_ACCRUAL
Contact: Dawn Lynn Nolt
Phone: 503-494-1080

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: CLOSED_TO_ACCRUAL
Contact: Philip M. Monteleone
Phone: 484-884-2201
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Philadelphia
Children's Hospital of Philadelphia
Status: CLOSED_TO_ACCRUAL
Contact: Richard Aplenc
Phone: 215-590-2810
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: CLOSED_TO_ACCRUAL
Contact: Jean M. Tersak
Phone: 412-692-5573

Puerto Rico

San Juan
San Jorge Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Luis A. Clavell
Phone: 787-727-1000

Rhode Island

Providence
Rhode Island Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jennifer J. Greene Welch
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321
Columbia
Prisma Health Richland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ronnie W. Neuberg
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nichole Leigh Bryant
Phone: 864-241-6251
Greenville Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Cary E. Stroud
Phone: 864-241-6251

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Manoo G. Bhakta
Phone: 865-331-1812
Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Adam John Esbenshade
Phone: 800-811-8480

Texas

Amarillo
Texas Tech University Health Sciences Center-Amarillo
Status: CLOSED_TO_ACCRUAL
Contact: Osvaldo Regueira
Phone: 888-823-5923
Corpus Christi
Driscoll Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nkechi Ifeoma Mba
Phone: 361-694-5311
Dallas
Medical City Dallas Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Naomi Joan Winick
Phone: 214-648-7097
Fort Sam Houston
Brooke Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Della Livesay Howell
Phone: 210-292-7311
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Julienne Brackett
Phone: 713-798-1354
Lubbock
Covenant Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kishor Mallikarjun Bhende
Phone: 806-775-8590
San Antonio
Children's Hospital of San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Timothy C. Griffin
Phone: 800-248-1199
Methodist Children's Hospital of South Texas
Status: CLOSED_TO_ACCRUAL
Contact: Gerardo Quezada
Phone: 210-575-7000
Temple
Scott and White Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Guy Howard Grayson
Phone: 254-724-5407

Vermont

Burlington
University of Vermont and State Agricultural College
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Homans
Phone: 802-656-4101

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kimberly Panter Dunsmore
Phone: 434-243-6322
Falls Church
Inova Fairfax Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Marshall A. Schorin
Phone: 703-208-6650
Norfolk
Children's Hospital of The King's Daughters
Status: CLOSED_TO_ACCRUAL
Contact: Eric Jeffrey Lowe
Phone: 757-668-7243
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Christina Marie Wiedl
Phone: 804-628-1939

Washington

Seattle
Seattle Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas S. Hawkins
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Judy L. Felgenhauer
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Melissa Anne Forouhar
Phone: 253-968-0129
Mary Bridge Children's Hospital and Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert G. Irwin
Phone: 800-552-1419

West Virginia

Charleston
West Virginia University Charleston Division
Status: CLOSED_TO_ACCRUAL
Contact: Ashley E. Meyer
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Stephan R. Paul
Phone: 304-293-2745

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: CLOSED_TO_ACCRUAL
Contact: John Robert Hill
Phone: 920-433-8889
Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Michael John McManus
Phone: 715-389-4457
Milwaukee
Children's Hospital of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Richard L. Tower
Phone: 414-805-4380

Alberta

Calgary
Alberta Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas R. Strother
Phone: 403-220-6898

British Columbia

Vancouver
British Columbia Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David Bryan Dix
Phone: 604-875-2345

Manitoba

Winnipeg
CancerCare Manitoba
Status: CLOSED_TO_ACCRUAL
Contact: John Joseph Doyle
Phone: 866-561-1026

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: CLOSED_TO_ACCRUAL
Contact: Lisa Anne Goodyear
Phone: 866-722-1126

Nova Scotia

Halifax
IWK Health Centre
Status: CLOSED_TO_ACCRUAL
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Carol A. Portwine
Phone: 905-521-2100ext74595
Kingston
Kingston Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Mariana Pradier Silva
Phone: 613-544-2630
London
Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shayna M. Zelcer
Phone: 519-685-8306
Ottawa
Children's Hospital of Eastern Ontario
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Mary Lewis Halton
Phone: 613-738-3931
Toronto
Hospital for Sick Children
Status: CLOSED_TO_ACCRUAL
Contact: Sarah Weeks Alexander
Phone: 416-813-7654ext2027

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: CLOSED_TO_ACCRUAL
Contact: Yvan Samson
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: CLOSED_TO_ACCRUAL
Contact: Sharon Barbara Abish
Phone: 514-412-4445

PRIMARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole.

SECONDARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin will result in a lower incidence of proven or probable cases of invasive aspergillosis (IA) compared with fluconazole. (Clinical)

II. To determine if prophylaxis with caspofungin will result in improved survival compared to fluconazole. (Clinical)

III. To determine if prophylaxis with caspofungin will result in less empiric antifungal therapy compared to fluconazole. (Clinical)

IV. To determine the sensitivity, specificity, and positive and negative predictive value of biweekly

galactomannan (GM) and beta-D glucan testing in diagnosing IFI. (Biological)

V. To test the association between single nucleotide polymorphisms (SNPs) in genes involved in innate immunity and proven or probable IFI. (Biological)

VI. To develop predictive models of IFI using SNP in genes involved in immunity and clinical covariates. (Biological)

OUTLINE: Patients are randomized to one of two treatment arms during their first chemotherapy course for AML.

ARM I: Patients receive caspofungin acetate intravenously (IV) over one hour once daily (QD) beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until absolute neutrophil count (ANC) > 100-500/uL following the nadir or the next chemotherapy course begins.

ARM II: Patients receive fluconazole IV over 1-2 hours or orally (PO) QD beginning within 24-72 hours following the last dose of chemotherapy for each course.

Protocol prophylaxis was continued in both arms, until ANC increased to > 100-500/uL following the nadir or the next chemotherapy course began. Prophylaxis was given for all courses of planned AML chemotherapy or until the patient met one of the following off-protocol therapy criteria: development of proven or probable IFI according to institutional diagnosis, initiation of conditioning for hematopoietic cell transplantation, initiation of a new chemotherapy regimen for relapsed or refractory AML, refusal of further protocol therapy by patient, parent or guardian, or physician determines it is in the best interest of the patient.

Regardless of duration of prophylaxis, subjects in both arms are monitored for IFI until the earliest of the following criteria is met: two weeks after recovery of neutropenia following the last planned AML chemotherapy course, initiation of conditioning for hematopoietic cell transplantation, initiation of a new chemotherapy regimen for relapsed or refractory AML, withdrawal of consent for any further data submission, or death.

Patients were followed for overall survival up to two years from enrollment.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
Children's Oncology Group

Principal Investigator
Theoklis E. Zaoutis

  • Primary ID ACCL0933
  • Secondary IDs NCI-2011-02640, COG-ACCL0933, CDR0000695748, S12-00316
  • Clinicaltrials.gov ID NCT01307579