Caspofungin Acetate in Treating Children With Fever and Neutropenia

June 17, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Tennessee
      • Memphis, Tennessee, United States, 38105-2794
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Thomas J. Walsh, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068564
  • NCI-01-C-0084C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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