Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive careActive3 months to 30 yearsNCI, OtherACCL0933
NCI-2011-02640, CDR0000695748, COG-ACCL0933, U10CA095861, NCT01307579

Trial Description

Summary

This randomized phase III trial studies caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin (caspofungin acetate) 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 1 of 2 treatment arms.

ARM I: Patients receive caspofungin acetate intravenously (IV) over 1 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 and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.

In both arms, treatment continues in the absence of invasive fungal infections or disease progression.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria

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
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Theoklis Zaoutis, MD MSCE, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

Alyssa T Reddy
Ph: 205-934-0309

Arizona
Phoenix

Phoenix Children's Hospital

Jessica Boklan
Ph: 602-546-0920

Arkansas
Little Rock

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

David L Becton
Ph: 501-364-7373

California
Downey

Southern California Permanente Medical Group

Robert M Cooper
Ph: 626-564-3455

Loma Linda

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Long Beach

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Theodore Zwerdling
Ph: 562-933-5600

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Madera

Children's Hospital Central California

Vonda L Crouse
Ph: 866-353-5437

Oakland

Kaiser Permanente-Oakland

Steven K Bergstrom
Ph: 626-564-3455

Orange

Children's Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Sacramento

University of California Davis Cancer Center

Jay Michael S Balagtas
Ph: 916-734-3089

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Mignon Loh
Ph: 877-827-3222

Colorado
Denver

Presbyterian - St. Luke's Medical Center

Jennifer J Clark
Ph: 866-775-6246

Connecticut
Hartford

Connecticut Children's Medical Center

Michael S Isakoff
Ph: 860-545-9981

New Haven

Yale Cancer Center

Nina S Kadan-Lottick
Ph: 203-785-5702

Delaware
Wilmington

Alfred I. duPont Hospital for Children

Christopher N Frantz
Ph: 302-651-5755

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Florida
Fort Lauderdale

Broward General Medical Center Cancer Center

Hector M Rodriguez-Cortes
Ph: 954-355-5346

Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Gainesville

UF Health Cancer Center

William B Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Hollywood

Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Jacksonville

Nemours Children's Clinic

Scott M Bradfield
Ph: 904-697-3529

Orlando

Florida Hospital Cancer Institute at Florida Hospital Orlando

Fouad M Hajjar
Ph: 407-303-5623

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Pensacola

Nemours Children's Clinic - Pensacola

Jeffrey H Schwartz
Ph: 904-697-3529

Saint Petersburg

All Children's Hospital

Gregory A Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Tampa

St. Joseph's Children's Hospital of Tampa

Mark J Mogul
Ph: 800-882-4123

West Palm Beach

Kaplan Cancer Center at St. Mary's Medical Center

Narayana Gowda
Ph: 888-823-5923
Email: ctsucontact@westat.com

Georgia
Atlanta

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Glen Lew
Ph: 404-785-1112

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W Wilkinson
Ph: 808-983-6090

Idaho
Boise

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Eugenia Chang
Ph: 800-845-4624

Illinois
Chicago

University of Illinois Cancer Center

Mary L Schmidt
Ph: 312-355-3046

Oak Lawn

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Rebecca E McFall
Ph: 847-723-7570

Springfield

Simmons Cooper Cancer Institute

Gregory P Brandt
Ph: 217-545-7929

Indiana
Indianapolis

Riley's Children Cancer Center at Riley Hospital for Children

Robert J Fallon
Ph: 317-274-2552

St. Vincent Indianapolis Hospital

Bassem I Razzouk
Ph: 317-338-2194

Iowa
Des Moines

Blank Children's Hospital

Wendy L Woods-Swafford
Ph: 515-241-6729

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Ayman A El-Sheikh
Ph: 800-237-1225

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Kenneth G Lucas
Ph: 866-530-5516

Louisiana
New Orleans

Children's Hospital of New Orleans

Lolie C Yu
Ph: 504-894-5377

Ochsner Cancer Institute at Ochsner Clinic Foundation

Craig Lotterman
Ph: 888-562-4763

Maine
Bangor

CancerCare of Maine at Eastern Maine Medical Center

Sarah J Fryberger
Ph: 207-973-4274

Maryland
Baltimore

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Joseph M Wiley
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Bethesda

National Naval Medical Center

Anne B Warwick
Ph: 301-319-2100

Massachusetts
Boston

Floating Hospital for Children at Tufts - New England Medical Center

Michael J Kelly
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Michigan
Ann Arbor

C.S. Mott Children's Hospital at University of Michigan Medical Center

Rajen Mody
Ph: 800-865-1125

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

Wayne State University

Meret Henry
Ph: 313-576-9363

East Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Renuka Gera
Ph: 517-975-9547

Flint

Hurley Medical Center

Susumu Inoue
Ph: 888-606-6556

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David S Dickens
Ph: 616-267-1925

Kalamazoo

Bronson Methodist Hospital

Jeffrey S Lobel
Ph: 800-227-2345

Western Michigan University School of Medicine Clinics

Jeffrey S Lobel
Ph: 800-227-2345

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Laura K Gowans
Ph: 248-551-7695

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Masonic Cancer Center at University of Minnesota

Peter M Gordon
Ph: 612-624-2620

Rochester

Mayo Clinic Cancer Center

Carola A. S. Arndt
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Columbia

Columbia Regional Hospital

Thomas W Loew
Ph: 573-882-7440

Kansas City

Children's Mercy Hospital

Maxine L Hetherington
Ph: 816-234-3265

Saint Louis

Cardinal Glennon Children's Hospital

William S Ferguson
Ph: 314-268-4000

David C. Pratt Cancer Center at St. John's Mercy

Bethany G. Sleckman
Ph: 913-948-5588

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Robert J Hayashi
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nebraska
Omaha

Children's Hospital

Minnie Abromowitch
Ph: 402-955-3949

Fred and Pamela Buffett Cancer Center

Minnie Abromowitch
Ph: 402-955-3949

Nevada
Las Vegas

Cancer Institute of Nevada at Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

CCOP - Nevada Cancer Research Foundation

Jonathan Bernstein
Ph: 702-384-0013

Children's Specialty Center of Nevada

Jonathan Bernstein
Ph: 702-384-0013

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

New Hampshire
Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Sara Chaffee
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey
Hackensack

Hackensack University Medical Center Cancer Center

Steven H Diamond
Ph: 201-996-2879

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Steven L Halpern
Ph: 973-971-5900

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Richard A Drachtman
Ph: 732-235-8675

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Paterson

St. Joseph's Hospital and Medical Center

Mary A Bonilla
Ph: 973-754-2909

Summit

Overlook Hospital

Steven L Halpern
Ph: 973-971-5900

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B Boayue
Ph: 505-272-6972

Theoklis E Zaoutis

New York
Albany

Albany Medical Center Hospital

Vikramjit S Kanwar
Ph: 518-262-3368

Bronx

Montefiore Medical Center

Peter D Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Buffalo

Roswell Park Cancer Institute

Martin L Brecher
Ph: 877-275-7724

Mineola

Winthrop University Hospital

Mark E Weinblatt
Ph: 866-946-8476

New Hyde Park

Schneider Children's Hospital

Mark P Atlas
Ph: 718-470-3470

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

New York University Medical Center

Linda Granowetter
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jeffrey R Andolina
Ph: 585-275-5830

Stony Brook

Stony Brook University Cancer Center

Robert I Parker
Ph: 800-862-2215

Syracuse

SUNY Upstate Medical University Hospital

Karol H Kerr
Ph: 315-464-5476

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Douglas J Scothorn
Ph: 828-213-4150

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Stuart H Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Charlotte

Presbyterian Cancer Center at Presbyterian Hospital

Paulette C Bryant
Ph: 704-384-5369

Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

Greenville

Leo W. Jenkins Cancer Center at ECU Medical School

Mauro Grossi
Ph: 252-744-2161

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Thomas W McLean
Ph: 336-713-6771

North Dakota
Fargo

Roger Maris Cancer Center at MeritCare Hospital

Samuel O Anim
Ph: 701-234-6161

Ohio
Akron

Akron Children's Hospital

Steven J Kuerbitz
Ph: 330-543-3193

Cincinnati

Cincinnati Children's Hospital Medical Center

John P Perentesis
Ph: 513-636-2799

Cleveland

Cleveland Clinic Taussig Cancer Center

Margaret C Thompson
Ph: 866-223-8100

Seidman Cancer Center at University Hospitals/Case Medical Center

Yousif (Joe) H Matloub
Ph: 216-844-5437

Columbus

Nationwide Children's Hospital

Mark A Ranalli
Ph: 614-722-2708

Dayton

Dayton Children's - Dayton

Emmett H Broxson
Ph: 800-228-4055

Toledo

Mercy Children's Hospital

Rama Jasty
Ph: 419-251-8210

Toledo Hospital

Jamie L Dargart
Ph: 419-824-1842

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Rene Y McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Tulsa

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Gregory B Kirkpatrick
Ph: 918-494-2200

Oregon
Portland

Knight Cancer Institute at Oregon Health and Science University

Dawn L Nolt
Ph: 503-494-1080
Email: trials@ohsu.edu

Legacy Emanuel Children's Hospital

Janice F Olson
Ph: 503-413-2560

Legacy Emanuel Hospital and Health Center and Children's Hospital

Janice F Olson
Ph: 503-413-2560

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M Monteleone
Ph: 484-884-2201

Danville

Geisinger Cancer Institute at Geisinger Health

Jagadeesh Ramdas
Ph: 570-271-5251

Philadelphia

Children's Hospital of Philadelphia

Richard Aplenc
Ph: 215-590-2810

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Rakesh K Goyal
Ph: 412-692-5573

PR
San Juan

San Jorge Children's Hospital

Luis A Clavell
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Carolina
Columbia

Palmetto Health South Carolina Cancer Center

Ronnie W. Neuberg
Ph: 803-434-3680

Greenville

BI-LO Charities Children's Cancer Center

Nichole L Bryant
Ph: 864-241-6251

Cancer Centers of the Carolinas - Faris Road

Cary E Stroud
Ph: 864-241-6251

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Kayelyn J Wagner
Ph: 605-328-1367

Tennessee
Nashville

Vanderbilt-Ingram Cancer Center

Adam Esbenshade
Ph: 800-811-8480

Texas
Corpus Christi

Driscoll Children's Hospital

M. C Johnson
Ph: 361-694-5311

Dallas

Medical City Dallas Hospital

Carl Lenarsky
Ph: 972-566-5588

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Naomi J Winick
Ph: 214-648-7097

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

Julienne Brackett
Ph: 713-798-1354
Email: burton@bcm.edu

Lubbock

Covenant Children's Hospital

Latha Prasannan
Ph: 806-725-8000
Email: jaccresearch@covhs.org

San Antonio

Children's Hospital of San Antonio

Timothy C Griffin
Ph: 713-798-1354
Email: burton@bcm.edu

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Temple

Scott and White Cancer Institute

Guy H Grayson
Ph: 254-724-5407

Vermont
Burlington

University of Vermont Cancer Center

Alan C Homans
Ph: 802-656-4101

Virginia
Charlottesville

University of Virginia Cancer Center

Kimberly P Dunsmore
Ph: 434-243-6143

Falls Church

Inova Fairfax Hospital

Marshall A Schorin
Ph: 703-208-6650

Norfolk

Children's Hospital of The King's Daughters

Eric J Lowe
Ph: 757-668-7243

Richmond

Virginia Commonwealth University Massey Cancer Center

Christina M Wiedl
Ph: 804-628-1939

Washington
Seattle

Children's Hospital and Regional Medical Center - Seattle

Douglas S Hawkins
Ph: 866-987-2000

Spokane

Providence Cancer Center at Sacred Heart Medical Center

Judy L Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

Tacoma

Madigan Army Medical Center - Tacoma

Melissa A Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Mary Bridge Children's Hospital and Health Center - Tacoma

Robert G Irwin
Ph: 253-403-3229

West Virginia
Charleston

West Virginia University Medical School - Charleston

Howard M Grodman
Ph: 304-388-9944

Morgantown

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Stephan R Paul
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Wisconsin
Green Bay

St. Vincent Hospital Regional Cancer Center

John R Hill
Ph: 920-433-8889

Marshfield

Marshfield Clinic - Marshfield Center

Michael J McManus
Ph: 715-389-4457

Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Richard L Tower
Ph: 414-805-4380

Canada

Alberta
Calgary

Alberta Children's Hospital

Douglas R Strother
Ph: 403-220-6898
Email: research4kids@ucalgary.ca

British Columbia
Vancouver

Children's and Women's Hospital of British Columbia

Caron Strahlendorf
Ph: 604-875-2345ext6477

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle A Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Newfoundland and Labrador
Saint John's

Janeway Children's Health and Rehabilitation Centre

Lisa Anne B Goodyear
Ph: 866-722-1126

Nova Scotia
Halifax

IWK Health Centre

Conrad V Fernandez
Ph: 902-470-8394

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Ph: 905-521-2100ext74595

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana P Silva
Ph: 613-544-2630

London

Children's Hospital of Western Ontario

Shayna M Zelcer
Ph: 519-685-8306

Toronto

Hospital for Sick Children

Sarah W Alexander
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Quebec
Montreal

Montreal Children's Hospital at McGill University Health Center

Sharon B Abish
Ph: 514-412-4445
Email: info@thechildren.com

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01307579
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.