Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

June 18, 2013 updated by: National Cancer Institute (NCI)

An Open-Label, Intravenous To Oral Switch, Multiple Dose, Multi-Center Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Hospitalized Children Aged 2 - <12 Years Who Require Treatment For The Prevention Of Systemic Fungal Infection

RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the pharmacokinetics of voriconazole administered IV and orally for the prevention of systemic fungal infection in pediatric patients with neutropenia after chemotherapy.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a pilot, open-label, multicenter study. Patients are stratified according to age (2 to 5 vs 6 to 11).

Within 48 hours after completion of chemotherapy, patients begin prophylactic therapy:

  • Cohort 1 (the first 18 patients, 9 per stratum): Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-8 and oral voriconazole* twice daily beginning on day 9.

Depending on the results of the interim pharmacokinetic analysis, the last 18 patients entered on the study receive 1 of the following regimens:

  • Cohort 2A:Patients receive voriconazole as in cohort 1 at a higher dose.
  • Cohort 2B: Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-4 and oral voriconazole* twice daily beginning on day 5.

NOTE: *Patients who are unable to tolerate oral medication may continue receiving IV medication until day 20.

In all cohorts, treatment continues until blood counts recover or day 30 in the absence of unacceptable toxicity or progression of infection.

Patients are followed at 30 days and at 12 months.

PROJECTED ACCRUAL: A total of 49 patients (approximately 24 per stratum) were accrued for this study within 1 year.

Study Type

Interventional

Phase

  • Phase 2

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
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Diego, California, United States, 92123-4282
        • Children's Hospital and Health Center, San Diego
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4318
        • Children's Hospital of Philadelphia
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

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 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Expected to develop neutropenia (absolute neutrophil count less than 500/mm^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions:

    • Leukemia
    • Lymphoma
    • Aplastic anemia
    • Preparation for a bone marrow or stem cell transplantation
  • Requiring treatment for the prevention of systemic fungal infection

PATIENT CHARACTERISTICS:

Age

  • 2 to 11

Performance status

  • Not specified

Life expectancy

  • More than 3 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • AST and ALT no greater than 5 times upper limit of normal (ULN)
  • Bilirubin no greater than 5 times ULN

Renal

  • Creatinine clearance at least 30 mL/min

Cardiovascular

  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No severe hypokalemia (potassium less than 3.2 mmol/L)
  • No prior hypersensitivity to or severe intolerance of azole antifungal agents
  • No other concurrent condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 24 hours since prior use of any of the following:

    • Terfenadine
    • Pimozide
    • Quinidine
    • Astemizole
    • Cisapride
    • Omeprazole

  • More than 14 days since prior use of any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenytoin
    • Nevirapine
    • Long-acting barbiturates
  • No prior sirolimus
  • No prior enrollment on this study

  • No concurrent use of any of the following:

    • Terfenadine
    • Pimozide
    • Quinidine
    • Astemizole
    • Cisapride
    • Omeprazole

  • No other concurrent investigational drugs except any of the following:

    • Drugs used as treatment for cancer
    • Antiretroviral agents
    • Drugs used for the treatment of any AIDS-defining opportunistic infections
  • No concurrent enrollment in investigational anticancer drug trials that exclude the use of other investigational agents

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

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

June 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000316329
  • NCI-03-C-0218

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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