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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 11, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caspofungin Acetate in Treating Children With Fever and Neutropenia
Official Title  ICMJE 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
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.
Detailed Description

OBJECTIVES:

  • 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Supportive Care
Condition  ICMJE
  • Fever, Sweats, and Hot Flashes
  • Infection
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Neutropenia
  • Sarcoma
Intervention  ICMJE Drug: caspofungin acetate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 2 to 17

Performance status:

  • Not specified

Life expectancy:

  • At least 5 days

Hematopoietic:

  • See Disease Characteristics
  • Hemodynamically stable with no hemodynamic compromise

Hepatic:

  • 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

Renal:

  • Not specified

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00020527
Other Study ID Numbers  ICMJE CDR0000068564
NCI-01-C-0084C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Cancer Institute (NCI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Thomas J. Walsh, MD National Cancer Institute (NCI)
PRS Account National Cancer Institute (NCI)
Verification Date March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP