Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActive6 months to 21 yearsNCI, OtherACCL0934
NCI-2011-02636, CDR0000695661, COG-ACCL0934, U10CA095861, NCT01371656

Trial Description

Summary

This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia.

SECONDARY OBJECTIVES:

I. To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis.

II. To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT.

III. To determine whether levofloxacin prophylaxis reduces the incidence of fever with neutropenia, severe infection, and death from bacterial infection.

IV. To assess the safety of levofloxacin prophylaxis, with specific attention to musculoskeletal disorders including tendinopathy and tendon rupture.

V. To assess the impact of prophylactic levofloxacin on the incidence of Clostridium difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented invasive fungal infections (IFI).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive levofloxacin orally (PO) or intravenously (IV) over 60-90 minutes once daily (QD) or twice daily (BID) beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

ARM II: Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

After completion of study therapy, patients are followed up for 1 year.

Eligibility Criteria

Inclusion Criteria:

  • Patient must fit 1 of the following 2 categories:
  • Chemotherapy patients
  • Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either:
  • De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy
  • Relapsed acute lymphoblastic leukemia (ALL)
  • For the purposes of this study, "intensive chemotherapy" is defined as regimens that are predicted by the local investigator to cause neutropenia for > 7 days; examples include, but are not limited to, treatment with "4-drug induction" (anthracycline, vincristine, asparaginase, and steroid), high dose cytarabine, anthracycline/cytarabine, ifosfamide/etoposide, and clofarabine-containing regimens
  • Stem cell transplantation patients
  • Planned to receive at least 1 myeloablative autologous or allogeneic HSCT
  • For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:
  • 0.5 mg/dL (6 months to < 1 year of age)
  • 0.6 mg/dL (1 to < 2 years of age)
  • 0.8 mg/dL (2 to < 6 years of age)
  • 1.0 mg/dL (6 to < 10 years of age)
  • 1.2 mg/dL (10 to < 13 years of age)
  • 1.5 mg/dL (male)/1.4 mg/dL (female) (13 to < 16 years of age)
  • 1.7 mg/dL (male)/1.4 mg/dL (female) (>= 16 years of age)
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT
  • Patients with an allergy to quinolones
  • Patients with chronic active arthritis
  • Patients with a known pathologic prolongation of the corrected QT (QTc)
  • Females who are pregnant or breast feeding
  • Patients being treated with antibacterial agents, other than any of the following:
  • Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis
  • Topical antibiotics
  • Central venous catheter antibiotic lock therapy
  • Note: prophylactic antifungal therapy is NOT an exclusion criterion
  • Patients currently enrolled on the ACCL1034 study are not eligible until they have completed the 90 day observation period of that study

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Sarah Alexander, MD, Principal Investigator

Trial Sites

U.S.A.

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

Duarte

City of Hope Comprehensive Cancer Center

Sarah W Alexander

Loma Linda

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Antranik A Bedros
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

Oakland

Children's Hospital and Research Center Oakland

Mark C Walters
Ph: 510-450-7600

San Diego

Rady Children's Hospital - San Diego

William D Roberts
Ph: 858-966-5934

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Christopher C Dvorak
Ph: 877-827-3222

Colorado
Aurora

Children's Hospital Colorado Center for Cancer and Blood Disorders

Kristen M Eisenman
Ph: 720-777-6672

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

Scott M Bradfield
Ph: 904-697-3529

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Florida
Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Jacksonville

Nemours Children's Clinic

Scott M Bradfield
Ph: 904-697-3529

Orlando

Nemours Children's Hospital

Scott M Bradfield
Ph: 904-697-3529

Pensacola

Nemours Children's Clinic - Pensacola

Scott M Bradfield
Ph: 904-697-3529

Saint Petersburg

All Children's Hospital

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

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

Augusta

Medical College of Georgia Cancer Center

Colleen H McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

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: 888-823-5923
Email: ctsucontact@westat.com

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

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Alexandra C Cheerva
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

Maryland
Baltimore

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

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

Massachusetts
Boston

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Carlos Rodriguez-Galindo
Ph: 866-790-4500

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

Rama Jasty
Ph: 419-251-8210

East Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Renuka Gera
Ph: 517-975-9547

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David S Dickens
Ph: 616-267-1925

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Saint Louis

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

Bethany G. Sleckman
Ph: 913-948-5588

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

Sunrise Hospital and Medical Center

Nik Farahana N Rashid
Ph: 702-384-0013

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

New Jersey
Hackensack

Hackensack University Medical Center Cancer Center

Steven H Diamond
Ph: 201-996-2879

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

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B Boayue
Ph: 505-272-6972

Sarah W Alexander

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

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

Valhalla

New York Medical College

Jessica C Hochberg
Ph: 914-594-3794

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Douglas J Scothorn
Ph: 828-213-4150

Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Thomas W McLean
Ph: 336-713-6771

Ohio
Akron

Akron Children's Hospital

Steven J Kuerbitz
Ph: 330-543-3193

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

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

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

L. C Bailey
Ph: 215-590-2810

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Arthur K Ritchey
Ph: 412-692-5573

South Carolina
Columbia

Palmetto Health South Carolina Cancer Center

Ronnie W. Neuberg
Ph: 803-434-3680

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Kayelyn J Wagner
Ph: 605-328-1367

Texas
Corpus Christi

Driscoll Children's Hospital

M. C Johnson
Ph: 361-694-5311

Dallas

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

Naomi J Winick
Ph: 214-648-7097

Fort Worth

Cook Children's Medical Center - Fort Worth

Gretchen M Eames
Ph: 682-885-2103

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

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

San Antonio

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

University of Texas Health Science Center at San Antonio

Anne-Marie R Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Virginia
Norfolk

Children's Hospital of The King's Daughters

Eric J Lowe
Ph: 757-668-7243

Washington
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

Wisconsin
Marshfield

Marshfield Clinic - Marshfield Center

Michael J McManus
Ph: 715-389-4457

Milwaukee

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

Paul D Harker-Murray
Ph: 414-805-4380

Canada

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

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

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

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline M Halton
Ph: 613-738-3931

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 NCT01371656
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.