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Caspofungin Acetate in Treating Children With Fever and Neutropenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00020527
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.

PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.

Condition or disease Intervention/treatment Phase
Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma Drug: caspofungin acetate Not Applicable

Detailed Description:


  • Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia.
  • Determine the safety and tolerability of this drug in this patient population.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to age (2 to 11 vs 12 to 17).

Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy, a breakthrough fungal infection, any deterioration of patient condition, or unacceptable toxicity.

Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels. Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1.

Patients are followed at 14 days.

PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia
Study Start Date : March 2001
Actual Study Completion Date : June 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Immunocompromised with one or more of the following conditions:

    • Leukemia, lymphoma, or other cancer
    • Underwent bone marrow or peripheral blood stem cell transplantation
    • Aplastic anemia
  • Planned chemotherapy likely to incur more than 10 days of neutropenia
  • Absolute neutrophil count no greater than 500/mm^3 AND at least 1 recorded fever over 38.0 ° C within 24 hours of study
  • No proven invasive fungal infection at time of study entry

    • Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or candidal vaginitis) treatable with topical antifungals allowed



  • 2 to 17

Performance status:

  • Not specified

Life expectancy:

  • At least 5 days


  • See Disease Characteristics
  • Hemodynamically stable with no hemodynamic compromise


  • AST or ALT no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases or other suspected bony processes)
  • INR no greater than 1.6 (4.0 if receiving anticoagulants)
  • No acute hepatitis or cirrhosis


  • Not specified


  • Functioning central venous catheter in place
  • No other condition or concurrent illness that would preclude study
  • No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception other than or in addition to oral contraceptives


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior enrollment into this study
  • No more than 48 hours since prior parenteral systemic antibacterial therapy for fever and neutropenia
  • At least 14 days since prior investigational antibiotic or antifungal drugs
  • Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a superficial fungal infection allowed
  • No other concurrent investigational drugs, including antibiotics or antifungals
  • No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or other antifungal treatments (except fluconazole)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020527

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United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Thomas J. Walsh, MD National Cancer Institute (NCI)
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ClinicalTrials.gov Identifier: NCT00020527    
Obsolete Identifiers: NCT00011219
Other Study ID Numbers: CDR0000068564
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: March 2003
Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood rhabdomyosarcoma
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
fever, sweats, and hot flashes
childhood acute promyelocytic leukemia (M3)
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
previously treated childhood rhabdomyosarcoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Hot Flashes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Body Temperature Changes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Leukocyte Disorders
Hematologic Diseases