Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant



Status:Active, not recruiting
Conditions:Cancer, Cancer, Blood Cancer, Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:Any - 20
Updated:1/25/2019
Start Date:March 21, 2013

Use our guide to learn which trials are right for you!

A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)

This randomized phase III trial studies how well caspofungin acetate works compared to
fluconazole or voriconazole in preventing fungal infections in patients following donor stem
cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in
preventing fungal infections in patients following donor stem cell transplant. It is not yet
known whether caspofungin acetate is more effective than fluconazole or voriconazole in
preventing fungal infections in patients following donor stem cell transplant.

PRIMARY OBJECTIVES:

I. To determine if caspofungin (caspofungin acetate) is associated with a lower incidence of
proven/probable invasive fungal infections (IFI) during the first 42 days following
allogeneic hematopoietic cell transplantation (HCT) at high-risk for IFI compared with azole
(fluconazole or voriconazole) prophylaxis.

SECONDARY OBJECTIVES:

I. To determine if caspofungin is associated with a lower incidence of proven/probable IFI
during the first 100 days following high-risk allogeneic HCT compared with azole (fluconazole
or voriconazole) prophylaxis. (Exploratory) II. To determine if caspofungin is associated
with a lower incidence of proven/probable IFI during the first 42 and 100 days following
high-risk allogeneic HCT compared with fluconazole prophylaxis. (Exploratory) III. To
determine if caspofungin is associated with a lower incidence of proven/probable IFI during
the first 42 and 100 days following high-risk allogeneic HCT compared with voriconazole
prophylaxis. (Exploratory) IV. To determine if caspofungin is associated with a superior
fungal-free survival (FFS) (time to death or proven/probable IFI) at 42 and 100 days
following high-risk allogeneic HCT compared with azole prophylaxis. (Exploratory) V. To
describe the effect that caspofungin and azoles have on the incidence and severity of acute
graft-versus-host disease (GVHD). (Exploratory) VI. To define the test characteristics of
weekly Fungitell assay testing for identifying IFI in pediatric hematopoietic stem cell
transplantation (HSCT) recipients receiving antifungal prophylaxis during the post-transplant
neutropenic period. (Exploratory) VII. To create a deoxyribonucleic acid (DNA) specimen bank
in anticipation of the development of biology correlative studies exploring the relationship
between IFI and single nucleotide polymorphisms (SNPs) of genes involved in immunity.
(Exploratory)

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 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the
absence of invasive fungal infections or disease progression.

ARM II: Patients receive fluconazole IV over 1-2 hours QD or orally (PO) QD; or voriconazole
IV over 1-2 hours QD or PO twice daily (BID) beginning within 24 hours of allogeneic HSCT
(day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or
disease progression.

After completion of study treatment, patients are followed up until day 100.

Inclusion Criteria:

- Age

- For centers that will use fluconazole as the antifungal comparator:

- Age >= 3 months and < 21 years

- For centers that will use voriconazole as the antifungal comparator:

- Age >= 2 years and < 21 years

- The patient must be undergoing allogeneic HCT from any donor (including matched
related) with any stem cell source for any underlying condition

- 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

- 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 (1 month to < 6 months of age)

- 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) or 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)

- Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to
Gilbert?s syndrome

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x
upper limit of normal (ULN) for 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:

- Within 90 days of enrollment:

- Patients with a proven or probable invasive mold infection are not eligible

- Patients with an incompletely treated invasive yeast infection are not eligible

- Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior
to time of enrollment (if performed) must have a full evaluation for invasive
aspergillosis (including a negative chest computed tomography [CT] scan) during
that time period to be eligible for enrollment

- Patients receiving treatment for an IFI are not eligible

- Patients with a history of echinocandin or azole hypersensitivity are not eligible

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants
We found this trial at
47
sites
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Rakesh K. Goyal
Phone: 412-692-5573
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Barbara J. Bambach
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Phone: 614-722-2708
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Carl Lenarsky
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Principal Investigator: David S. Dickens
Phone: 616-267-1925
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Gail C. Megason
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Maxine L. Hetherington
Phone: 816-234-3265
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
747 52nd St
Oakland, California 94609
(510) 428-3000
Principal Investigator: Mark C. Walters
Phone: 510-450-7600
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Violet Shen
Phone: 714-997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: David M. Barrett
Phone: 215-590-2810
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Principal Investigator: Jaime Estrada
Phone: 210-575-7000
Methodist Children's Hospital of South Texas Methodist Children
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: William D. Roberts
Phone: 858-966-5934
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Scott M. Bradfield
Phone: 904-697-3529
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
Akron, Ohio 44308
Principal Investigator: Steven J. Kuerbitz
Phone: 330-543-3193
?
mi
from
Akron, OH
Click here to add this to my saved trials
1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
Principal Investigator: John E. Levine
Phone: 800-865-1125
C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30322
Principal Investigator: Ann E. Haight
Phone: 888-785-1112
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boston, Massachusetts 02111
Principal Investigator: Michael J. Kelly
Phone: 617-636-5000
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10467
Principal Investigator: Peter D. Cole
Phone: 718-904-2730
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Margaret C. Thompson
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Roland L. Chu
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Jennifer A. Krajewski
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert J. Fallon
Phone: 317-274-2552
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jacksonville, Florida 32207
Principal Investigator: Scott M. Bradfield
Phone: 904-697-3529
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Antranik A. Bedros
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-4272
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
8200 Dodge St
Omaha, Nebraska 68114
(402) 955-5400
Principal Investigator: Minnie Abromowitch
Phone: 402-955-3949
Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Peter F. Coccia
Phone: 800-999-5465
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Principal Investigator: Neyssa M. Marina
Phone: 650-498-7061
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Christopher C. Dvorak
Phone: 877-827-3222
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Shakila P. Khan
Phone: 507-538-7623
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84143
Principal Investigator: Meghann P. McManus
Phone: 423-778-7289
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94158
?
mi
from
San Francisco, CA
Click here to add this to my saved trials